tag:blogger.com,1999:blog-11027129793455617142024-03-23T19:00:30.284+08:00Lecture Notes in Medical TechnologyMT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.comBlogger343125tag:blogger.com,1999:blog-1102712979345561714.post-49980474301388351822023-07-26T17:04:00.000+08:002023-07-26T17:04:16.187+08:00Antibiotic, Probiotic & Lantibiotic<p><span style="color: #01ffff; font-size: medium;"> </span></p><p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Chemotherapeutic agents are chemical substances used
for the treatment of infectious diseases or diseases caused by the
proliferation of malignant cells. These substances are prepared in the
laboratory or obtained from microorganisms and some plants and animals. In
general, naturally occurring substances are distinguished from synthetic
compounds by the name antibiotics. Some antibiotics are prepared synthetically
but most of them are produced commercially by biosynthesis. Microorganisms producing
the largest number of useful antibiotics belong to the genera Bacillus,
Penicillium, Streptomyces and Cephalosporium in addition to other
chemotherapeutic agents like sulfonamides, nitrofurantoin, etc.</span></span></p><p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"><br /></span></span></p>
<p class="MsoNoSpacing"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Criteria in choosing a useful chemotherapeutic
agent:</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">It
must demonstrate selective toxicity for the disease agent.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The
host should not become allergic (hypersensitive) to the drug.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The
host should not destroy, neutralize or excrete the drug too rapidly.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The
organism should not readily become resistant to the drug. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The
drug should reach the site of infection.</span></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="2" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 235.8pt;" valign="top" width="314">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">SPECTRUM
OF ACTIVITY<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" valign="top" width="154">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">NARROW SPECTRUM<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">BROAD SPECTRUM<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Penicillin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Chlorampenicol<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Streptomycin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Chlortetracycline<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Erythromycin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Demeclocycline<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Lincomycin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Oxytetracycline<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Polymyxin B <span style="mso-tab-count: 1;"> </span><o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Tetracycline and derivatives<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Colistin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Ampicillin<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Vancomycin<span style="mso-tab-count: 1;"> </span><o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Cephalothin<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Nystatin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Gentamycin<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Spectinomycin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Rifampin<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" valign="top" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Tobramycin<span style="mso-tab-count: 1;"> </span><o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 115.15pt;" valign="top" width="154">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.65pt;" valign="top" width="161">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Paromomycin<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><br /></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" valign="top" width="177">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">MODE
OF ACTION<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">ANTIBIOTIC<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" valign="top" width="193">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">TARGET<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" width="177">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Compete with PABA (para–aminobenzoic acid)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Sulfonamides<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Enteric urinary tract infection<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">PAS (para–aminosalicylic acid)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Mycobacterium tuberculosis<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Trimethoprim<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Broad spectrum activity<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Compete with pyridoxine<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Mycobacterium tuberculosis<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" width="177">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Disrupt cell membrane<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Polymyxins<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Gram negative bacteria<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Polyene antibiotics<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">(Nystatin, Amphotericin B)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Fungi <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td rowspan="5" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" width="177">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Inhibit cell wall peptidoglycan synthesis <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Penicillin<o:p></o:p></span></span></p>
</td>
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Mostly Gram (+) bacteria<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Cephalosporin<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Bacitracin<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Vancomycin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Ristocetin <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" width="177">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Inhibit RNA synthesis<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Rifampin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Gram (+) bacteria<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" width="177">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Inhibit DNA synthesis<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Mitomycin & Actinomycin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Nalidixic acid<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Gram (–) bacteria of UTI etiology<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Novobiocin<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Gram (+) bacteria <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Griseofluvin <span style="mso-tab-count: 1;"> </span><o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Fungi<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" width="177">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Inhibit purine synthesis <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Trimethoprim<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Broad spectrum antibiotic<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.0pt;" width="177">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Inhibit protein synthesis <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Chloramphenicol<o:p></o:p></span></span></p>
</td>
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 144.6pt;" width="193">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Broad spectrum antibiotic mostly gram (+) bacteria<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19; mso-yfti-lastrow: yes;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Macrolide antibiotics (Erythromycin, Olendomycin<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Carbomycin, Spiramycin<span style="mso-tab-count: 1;"> </span><o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Lincomycin, Clindamycin<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Tetracycline, Streptomycin)<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table></div>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Some organisms develop a tolerance for a new
environmental condition and these organisms are referred to as drug fast or
drug resistant. Drug resistance may be due to a pre–existing factor in microorganisms
or it may be due to some acquired factors.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Emergence of drug resistance can be minimized by</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Maintaining
sufficiently high levels of the drug in the tissues to inhibit both the
original population and first step mutant.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Simultaneously
administer two drugs that do not give cross resistance, each of which delays
the emergence of mutant resistant to the other drug.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Avoiding
exposure to a particularly valuable drug by restricting its use, especially in
hospitals.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Some the of Antibiotic Resistant (ABR) Bacteria:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">MRSA
– Methicillin–Resistant Staphylococcus aureus<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">VRE
– Vancomycin–Resistant Enterococcus <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">CRE
– Carbapenem–Resistant Enterobacteriaceae (CRE) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">CRAB
– Carbapenem resistant Acinetobacter baumannii <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">MDR–TB
– Multi–Drug–Resistant Mycobacterium tuberculosis</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Except for
Mycobacterium, most of the bacteria enumerated belongs to ESKAPE bacteria group
which are a group of opportunistic pathogens consisting of Enterococcus
faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii,
Pseudomonas aeruginosa, and Enterobacter species characterized by increased
levels of resistance towards multiple classes of first line and last–resort
antibiotic.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">ESKAPE pathogens
are mainly responsible for nosocomial infections and these infections are
defined as hospital–acquired infections (HAIs) that affect patients within 48 hours
of admission or 3 days of discharge or 30 days of an operation. No literature
is available regarding the exact characteristics that classify bacteria under
ESKAPE.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">ESKAPE pathogens
are resistant to oxazolidinones, lipopeptides, macrolides, fluoroquinolones,
tetracyclines, β-lactams, β-lactam–β-lactamase inhibitor combinations, and
last-line antibiotics including carbapenems, glycopeptides, and polymyxins.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The mechanisms of multidrug resistance exhibited by
ESKAPE are broadly grouped into three categories namely:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Drug
inactivation is commonly caused by an irreversible cleavage catalyzed by an
enzyme.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Modification
of the target site where the antibiotic may bind.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Reduced
accumulation of drug either due to reduced permeability or by increased efflux
of the drug.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">They are also able to form biofilms that physically
prevent the immune response cells of host as well as antibiotics to inhibit the
pathogen. Moreover, biofilms protect specialized dormant cells called persister cells that are tolerant to antibiotics which
cause difficult-to-treat recalcitrant infections.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">THE
LANTIBIOTICS</span></span></b></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Bacteriocins are antimicrobial substances produced
by lactic acid bacteria (LAB), including organic acids, hydrogen peroxide,
diacetyl, and inhibitory enzymes. The bacteriocin producer expresses immunity
proteins to protect themselves from the bacteriocin they produce, and little
was known about these proteins.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Lantibiotics are peptide-derived antimicrobial
agents that are produced by the ribosomes and post–translationally modified to
their biologically active forms.</span></span></p>
<p class="MsoNoSpacing"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Classification of Bacteriocins:</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Class
I bacteriocins (lantibiotics) are small (<5 kDa) peptides containing the
unusual amino acids lanthionine (Lan), β-methyllanthionine (MeLan) and several
dehydrated amino acids. They are heat–stable and mainly induce destabilization
and permeabilization of the bacterial membranes or cause pore formation into
the membrane.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Examples include
Nisin, Lacticin 481, and the two-component lantibiotics such as cytolysin
produced by Enterococcus faecalis, lacticin 3147 produced by L. lactis, and
staphylococcin C55 produced by Staphylococcus aureus.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Class
II bacteriocins are small thermostable peptides with an amphiphilic helical structure that allows for their insertion in
the cytoplasmic membrane of the target cell, thereby promoting membrane
depolarization and cell death.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Subclass
IIa – often designated as pediocin–like bacteriocins, constitutes the most
dominant group of antimicrobial peptides produced by lactic acid bacteria. The
bacteriocins that belong to this class are structurally related and kill target
cells by membrane permeabilization (e.g., Pediocin PA-1, Sakacin A, and Enterocin
A).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Subclass
IIb – the activity of these bacteriocins depends on the complementary activity
of two peptides. The combined effect of the two peptides of these bacteriocins
is much greater than the total activity calculated from the individual effect
of these peptides (e.g., Lactococcin G, Lacticin F).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Subclass
IIc – also known as “Circular Bacteriocins.” They consist of the cyclic
bacteriocins whose N– and C–termini are covalently linked, and the circular
molecule is resistant to several proteases and peptidases (e.g., Acidocin B).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Subclass
IId – contains the one-peptide non-cyclic bacteriocins that show no sequence
similarity to the pediocin-like bacteriocins.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Class
III are large (>30 kDa) heat-labile proteins that are capable of degrading
cell wall murein. This group includes some colicins, zoocins, megacins
(Bacillus megaterium), klebicin (Klebsiella pneumonia), helveticins I and J
(Lactobacillus helveticus), and enterolysin A (Enterococcus faecalis). The new
class III bacteriocin BLF3872 from LF3872 has not yet been studied.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Class
IV, the “complex bacteriocins” has also been suggested, which require
non-proteinaceous moieties for activity. This class, however, has not been
sufficiently studied at the biochemical level.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Studies on the genetics and biochemistry of
bacteriocins have principally focused on members of Class I and II, due to the
abundance of these peptides and their potential commercial applications.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><br /></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: medium;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">THE
PROBIOTICS</span></b></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Probiotics are live microorganisms that are intended
to have health benefits when consumed or applied to the body. They can be found
in yogurt and other fermented foods, dietary supplements, and beauty products.
The most common are bacteria that belong to groups called Lactobacillus and
Bifidobacterium. Other bacteria may also be used as probiotics, and so may
yeasts such as Saccharomyces boulardii.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Prebiotics are food supplements that are
nondigestible by the host but can exert beneficial effects by selective
stimulation of growth or activity of microorganisms that are present in the
intestine.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For a potential probiotic strain to exert its
beneficial effects, it is expected to exhibit certain desirable properties. The
ones currently determined by in vitro tests are:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Acid
and bile tolerance which seems to be crucial for oral administration,</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Adhesion
to mucosal and epithelial surfaces, an important property for successful immune
modulation, competitive exclusion of pathogens, as well as prevention of
pathogen adhesion and colonisation,</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Antimicrobial
activity against pathogenic bacteria,</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Bile
salt hydrolase activity.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">There is increasing evidence in favor of the claims
of beneficial effects attributed to probiotics, including improvement of
intestinal health, enhancement of the immune response, reduction of serum
cholesterol, and cancer prevention. These health properties are strain specific
and are impacted by the various mechanisms mentioned above. While some of the
health benefits are well documented others require additional studies to be
established. In fact, there is substantial evidence to support probiotic use in
the treatment of acute diarrheal diseases, prevention of antibiotic-associated
diarrhea, and improvement of lactose metabolism, but there is insufficient
evidence to recommend them for use in other clinical conditions.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Recent evidence suggests that exposure to bacteria
in early life may exhibit a protective role against allergy and in this
context, probiotics may provide safe alternative microbial stimulation needed
for the developing immune system in infants.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Evidence also suggests that food products containing
probiotic bacteria could possibly contribute to coronary heart disease
prevention by reducing serum cholesterol levels as well as to blood pressure
control.</span><span style="font-size: 12pt;"><o:p></o:p></span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-52218410068660235242023-07-11T21:57:00.001+08:002023-07-11T22:00:02.577+08:00The Free-Living Amoeba<p><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
classical taxonomic classification divided the Protozoa into four groups:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Sarcodina
(amoebae)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Mastigophora
(flagellates)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Sporozoa
(most parasitic protozoa)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Infusoria
(ciliates)</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This
taxonomy has been totally abandoned by the International Society of Protozoologists
based on modern morphological approaches such as<b> biochemical pathways and molecular
phylogenetics </b>(e.g., 18S rRNA sequences). The older hierarchical systems consisting
of the traditional “kingdom,” “phylum,” “class,” “subclass,” “super-order,” “order,”
has been replaced by a new vocabulary.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">According
to this new schema, the Eukaryotes have been classified into six clusters or “Super
Groups,” namely:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Amoebozoa<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Opisthokonta<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Rhizaria<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Archaeplastida
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Chromalveolata<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Excavata</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
three amoebae that are dealt within this article have been classified under two
Super Groups, Amoebozoa and Excavata, as follows:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Acanthamoeba
and Balamuthia are classified under Super Group Amoebozoa: Acanthamoebidae</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Naegleria
fowleri under Super Group Excavata: Heterolobosia: Vahlkampfiidae</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This
schema has been proposed as the basis for future revisions.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">For
educational purposes, the classic phylogeny of the parasite was described here.
And unlike amoeba belonging to Phylum Sarcodina that requires host to survive,
parasites belonging in this group are free living (i.e., doesn’t require host
to survive). <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p align="center" class="MsoNoSpacing" style="background: #E5E5E5; mso-pattern: gray-10 auto; mso-shading: windowtext; text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: large;">NAEGLERIA
FOWLERI</span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Phylum
Percolozoa<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Subphylum
Tetramitia<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Order
Schizopyrenida <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Family
Vahlkampfiidae<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Genus
Naegleria</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Naegleria
fowleri is an amphizoic amoeba, as it can survive in a free-living state in
water, soil, or in the host, which can be the human central nervous system
(CNS) and causes a disease known as Primary Amebic Meningoencephalitis (PAM)
thus its reputation as "brain-eating amoeba."</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
initial symptoms of PAM are indistinguishable from bacterial meningitis, while
the symptoms of GAE can mimic a brain abscess, encephalitis, or meningitis.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
amoeboid stage is roughly cylindrical, typically around 20–40 μm in length.
They are traditionally considered lobose amoebae, but are not related to the
others, and unlike them, do not form true lobose pseudopods. Instead, they
advance by eruptive waves, where hemispherical bulges appear from the front
margin of the cell, which is clear. The flagellate stage is slightly smaller,
with two or four anterior flagella anterior to the feeding groove.</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiU6Vtwa2tWHYYYgYBQUBn_aNYHG4v3IpCvBAkzZrer4Mc_NLnfkQvUVt3BErZQAtxzarY_Lo_s4mf8FF8oTnz6xwaMyMeF-Ml0Rzc3Z0PrMEPQKZCaoFVMr7cN71nwsuYkoKoHsX89nD8n_aTQTnLiyhvgC84RQqNZuu9QjjmqJP8LgwPmbggeb_-Tgfk/s597/Naegleria%20Transmission.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="440" data-original-width="597" height="472" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiU6Vtwa2tWHYYYgYBQUBn_aNYHG4v3IpCvBAkzZrer4Mc_NLnfkQvUVt3BErZQAtxzarY_Lo_s4mf8FF8oTnz6xwaMyMeF-Ml0Rzc3Z0PrMEPQKZCaoFVMr7cN71nwsuYkoKoHsX89nD8n_aTQTnLiyhvgC84RQqNZuu9QjjmqJP8LgwPmbggeb_-Tgfk/w640-h472/Naegleria%20Transmission.jpg" width="640" /></a></div><p></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Naegleria
fowleri has been thought to infect the human body by entering the host through
the nose when water is splashed or forced into the nasal cavity. Infectivity
occurs first through attachment to the nasal mucosa, followed by locomotion
along the olfactory nerve and through the cribriform plate (which is more
porous in children and young adults) to reach the olfactory bulbs within the CNS.
Once Naegleria fowleri reaches the olfactory bulbs, it elicits a significant
immune response through activation of the innate immune system, including
macrophages and neutrophils. <b>Naegleria fowleri enters the human body in the
trophozoite form</b>. Structures on the surface of trophozoites known as <b>food
cups</b> enable the organism to ingest bacteria, fungi, and human tissue. In
addition to tissue destruction by the food cup, the pathogenicity of Naegleria
fowleri is dependent upon the release of cytolytic molecules, including acid
hydrolases, phospholipases, neuraminidases, and phospholipolytic enzymes that
play a role in host cell and nerve destruction. The combination of the
pathogenicity of Naegleria fowleri and the intense immune response resulting
from its presence results in significant nerve damage and subsequent CNS tissue
damage, which often result in death.</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-FBmchn4dE514RyOuLIsEUXBg-9sld-FnZcxneNKu_qSNynkzPmRmhEcLLWWaaQvqfZJCQyWdYo-VE7yAUXESu8aZIYweOveLW43pjZIHc2Ut4zur9Dr0UnFzOKMgp-Bnc45wHsaSI0_DsDzOqfB1pet2s4Vb1xtt5BaL8THqJau-tlmlI5SeSjDiQwk/s850/Naegleria%20CSF%20Troph.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="255" data-original-width="850" height="192" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-FBmchn4dE514RyOuLIsEUXBg-9sld-FnZcxneNKu_qSNynkzPmRmhEcLLWWaaQvqfZJCQyWdYo-VE7yAUXESu8aZIYweOveLW43pjZIHc2Ut4zur9Dr0UnFzOKMgp-Bnc45wHsaSI0_DsDzOqfB1pet2s4Vb1xtt5BaL8THqJau-tlmlI5SeSjDiQwk/w640-h192/Naegleria%20CSF%20Troph.png" width="640" /></a></div><p></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
quickest way to diagnose Naegleria fowleri infection is by microscopic
examination of fresh, unfrozen, unrefrigerated cerebrospinal fluid (CSF).</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Both
chlorinated and salt water significantly decrease the risk of Naegleria fowleri
infection due to its inability to survive in such environments. Thus, avoidance
of exposure to freshwater bodies such as lakes, rivers, and ponds, especially
during the summer months when the water temperature is higher.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p align="center" class="MsoNoSpacing" style="background: #E5E5E5; mso-pattern: gray-10 auto; mso-shading: windowtext; text-align: center;"><span style="font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">ACANTHAMOEBA
SPP.</span></b><b style="color: #01ffff;"><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Phylum
Amoebozoa<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Class
Conosea<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Order
Centramoeba<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Family
Acanthamoeba</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Some
of the pathogenic species:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Acanthamoeba
castellanii<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Acanthamoeba
culbertsoni<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Acanthamoeba
polyphaga<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Acanthamoeba
healyi<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Acanthamoeba
divionensis</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Diseases
caused by Acanthamoeba include keratitis and granulomatous amoebic encephalitis
(GAE).</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Acanthamoeba
keratitis (AK) is associated with trauma to the cornea or contact-lens wear and
the use of amoeba–contaminated saline. Minor erosion of the corneal epithelium may
occur while wearing hard or soft contact lenses, and the subsequent use of contaminated
saline solution is the major risk factor for Acanthamoeba keratitis. AK is characterized
by inflammation of the cornea, severe ocular pain, and photophobia, a characteristic
360<sup>o</sup> or paracentral stromal ring infiltrate, recurrent breakdown of corneal
epithelium, and a corneal lesion refractory to the commonly used antibiotics. Typically,
only one eye is involved; however, bilateral keratitis has also been reported. It
is the MBP (mannose binding protein) that mediates the adhesion of the amoeba to
corneal epithelial cells and is central to the pathogenic potential of Acanthamoeba.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">A
unique and characteristic feature of Acanthamoeba spp. is the presence of fine,
tapering, thorn-like <b>acanthopodia</b> that arise from the surface of the body.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
trophozoites range in size from 15 to 50mm depending upon the species. They are
uninucleate, and the nucleus has a centrally placed, large, densely staining nucleolus.
The cytoplasm is finely granular and contains numerous mitochondria, ribosomes,
food vacuoles, and a contractile vacuole. When food becomes scarce, or when it is
facing desiccation or other environmental stresses, the amoebae round up and encyst.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo7; text-indent: -18.0pt;"><span style="color: #01ffff; font-size: large;"></span></p><div class="separator" style="clear: both; text-align: center;"><span style="color: #01ffff; font-size: large;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVdqmk09PndNvfymEZTaFoQxTzPVHsXFXQK-dA2978E-NU_PX62SbXgPn5wkOvUtBPTTKpMdCGquQS--02ueyvFb_eAhs694sLRjoXSWS7wR1058ts4xV2CqTAQ-1mYdVgr0OpRBYYtVUaYrhQZifZjuK0cXVgHH07HZYP1C-JyCypwcjxw4JCT3RNyPw/s1050/Acanthamoeba%20Life%20cyst%20phase%20contrast2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="389" data-original-width="1050" height="238" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVdqmk09PndNvfymEZTaFoQxTzPVHsXFXQK-dA2978E-NU_PX62SbXgPn5wkOvUtBPTTKpMdCGquQS--02ueyvFb_eAhs694sLRjoXSWS7wR1058ts4xV2CqTAQ-1mYdVgr0OpRBYYtVUaYrhQZifZjuK0cXVgHH07HZYP1C-JyCypwcjxw4JCT3RNyPw/w640-h238/Acanthamoeba%20Life%20cyst%20phase%20contrast2.jpg" width="640" /></a></span></div><p></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Cysts
are double-walled and range in size from 10 to 25mm. Cysts are uninucleate and possess
a centrally placed dense nucleolus. Upon return to favourable growth conditions,
the dormant amoeba is activated to leave the cyst by dislodging the operculum and
reverting to a trophic form</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
outer cyst wall, the ectocyst, is wrinkled with folds and ripples and contains protein
and lipid.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
inner cyst wall, the endocyst, contains cellulose and hence is Periodic Acid Schiff
(PAS) positive. The endocyst varies in shape: it may best ellate, polygonal, oval,
or spherical.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Pores
or ostioles that are covered by convex–concave plugs or opercula are present at
the junction of the ectocyst and the endocyst.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In either the trophic or the cyst stage these
organisms have a wide distribution in nature, and it is virtually impossible not
to isolate members of this genus from soil, water, and other samples.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgg1DcK0560JB6JO871zWtU9HaIMvLLl_1k1U4Nw3Z2V4sIYYR-pxv37lwO5cHuXh5VPMtjDgiYhpDuIbmY-m3Zs6RWZxr6tU8m73QbMtr4FHhhVFz20J36EJmecEq6G2w7LrvXnP2O0a9eNNQAgRJptonAilGIo3jfI4mgGTChdI7kMR-ups4vm7GQD6A/s813/Acanthamoeba%20Life%20cycle.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="498" data-original-width="813" height="392" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgg1DcK0560JB6JO871zWtU9HaIMvLLl_1k1U4Nw3Z2V4sIYYR-pxv37lwO5cHuXh5VPMtjDgiYhpDuIbmY-m3Zs6RWZxr6tU8m73QbMtr4FHhhVFz20J36EJmecEq6G2w7LrvXnP2O0a9eNNQAgRJptonAilGIo3jfI4mgGTChdI7kMR-ups4vm7GQD6A/w640-h392/Acanthamoeba%20Life%20cycle.jpg" width="640" /></a></div><p></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Acanthamoeba
spp. Are ubiquitous and occur worldwide. They have been isolated from soil, fresh
and brackish waters, bottled mineral water, cooling towers of electric and nuclear
power plants, heating, ventilating and air conditioning units, humidifiers, Jacuzzi
tubs, hydrotherapy pools in hospitals, dental irrigation units, dialysis machines,
dust in the air, bacterial, fungal and mammalian cell cultures, contact-lens paraphernalia,
ear discharge, pulmonary secretions, swabs obtained from nasopharyngeal mucosa of
patients with respiratory complaints as well as of healthy individuals, maxillary
sinus, mandibular autografts, and stool samples. In addition, several Acanthamoeba
species have been isolated from the brain, lungs, skin, and cornea of infected individuals.</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p align="center" class="MsoNoSpacing" style="background: #E5E5E5; mso-pattern: gray-10 auto; mso-shading: windowtext; text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: large;">BALAMUTHIA
MANDRILLARIS</span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Balamuthia
mandrillaris is a free-living amoeba that is found in the soil and fresh water
and is associated with Granulomatous Amoebic Encephalitis (GAE), a “brain-eating”
disease both in humans and animals. Symptoms of granulomatous amebic
encephalitis begin gradually. Confusion, headache, and seizures are common.
People may have a low-grade fever, blurred vision, changes in personality, and
problems with speaking, coordination, or vision. One side of the body or face
may become paralyzed.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Balamuthia
mandrillaris may cause skin sores in addition to the symptoms above. Most
infected people die, usually 7 to 120 days after symptoms begin.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Possible
modes of transmission of Balamuthia include inhalation and inoculation through
broken skin.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Balamuthia
mandrillaris, like Acanthamoeba, has only two life-cycle stages, namely the vegetative
trophozoite and the dormant cyst.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
trophozoite is pleomorphic and measures from 12 to 60 µm (mean of 30 µm). The
trophic amoebae are usually uninucleate, although binucleate forms are occasionally
seen. The nucleus contains a large, centrally placed, dense nucleolus;
occasionally, however, amoebae with two or three nucleolar bodies have been
seen, especially in infected tissues.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><span style="color: #01ffff; font-size: large;"></span></p><div class="separator" style="clear: both; text-align: center;"><span style="color: #01ffff; font-size: large;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFm4y2__UGUEhPLWIkvQSeBcjZ-AEEMTZCcwyGers1-VRoTtmJZ_bv-RVX5blk1XtJJjquHFGyddjl_Ltz0-a-HlM3VTR0mHTyySOZDbyfuPetWmDIEiq_RUa9GesAJyK3jSSTVm2tF_gRrOSa3O65Hpf8a_znxR0dB_IdzsGjyNdN-xUdtaG4FME-LlU/s761/Balamuthia%20Cyst%20Trop%20Brain.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="361" data-original-width="761" height="304" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFm4y2__UGUEhPLWIkvQSeBcjZ-AEEMTZCcwyGers1-VRoTtmJZ_bv-RVX5blk1XtJJjquHFGyddjl_Ltz0-a-HlM3VTR0mHTyySOZDbyfuPetWmDIEiq_RUa9GesAJyK3jSSTVm2tF_gRrOSa3O65Hpf8a_znxR0dB_IdzsGjyNdN-xUdtaG4FME-LlU/w640-h304/Balamuthia%20Cyst%20Trop%20Brain.jpg" width="640" /></a></span></div><p></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Cysts
are also uninucleate, are spherical, and range in size from 12 to 30 µm (mean
of 15 µm). Cysts, when examined with a light microscope, appear to be double
walled, the outer wall being wavy and the inner wall round, and pores are not
seen in the wall. Ultrastructurally, however, the cyst wall has three layers: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l3 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">an
outer thin and irregular ectocyst, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l3 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">an
inner thick endocyst, and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l3 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">a
middle amorphous fibrillar mesocyst.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In
general, Acanthamoeba spp. and Balamuthia are difficult to differentiate in
tissue sections by light microscopy because of their similar morphology.
However, they can be differentiated by immunofluorescence analysis of the
tissue sections using rabbit anti–Acanthamoeba or anti–B–mandrillaris sera.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">While
Balamuthia and Naegleria share some similarities, Balamuthia is more difficult
to detect. This is due to its resemblance to histiocytes under the microscope and
unique culture requirements. Unlike Naegleria, Balamuthia cannot be grown on
agar because it only feeds on mammalian cells and other amoebas. Furthermore,
healthy individuals can be seropositive for Balamuthia antibodies due to the
amoeba’s pervasive presence in the environment, while those with GAE show low
titers. Additionally, cerebrospinal fluid analysis rarely demonstrates the
organism, and the time course for the appearance of lesions and the onset of
GAE is inconsistent. Balamuthia, unlike most of other free-living amoebae, does
not feed on Gram-negative bacteria and therefore the use of non-nutrient agar coated
with bacterial cultures has resulted to be ineffective for its growth.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">These
amoebae were normally cultured on monolayers of African green monkey kidney
cells. Upon axenic cultivation, amoebae grew at various temperatures ranging
from 25°C to 37°C (optimal growth at 37°C) and remained viable for up to
several months, but they became smaller over time. In contrast, mammalian
cultures can be used persistently as feeder cells to culture Balamuthia amoebae
over longer periods, without any modifications in their general appearance. All
tested cell cultures, including human brain microvascular endothelial cells
(HBMEC), human lung fibroblasts, monkey kidney (E6) cells, and African green
monkey fibroblast-like kidney (Cos-7) cells, supported the growth of B.
mandrillaris.</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-46596708985151399092023-05-29T20:27:00.000+08:002023-05-29T20:27:38.241+08:00Department Memorandum No. 2021 – 0017<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">04 January 2021<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> </span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;"><span style="font-size: x-large;">INTERIM GUIDELINES ON PRE–EXPOSURE PROPHYLAXIS (PrEP)
FOR THE PREVENTION OF HIV INFECTION IN THE PHILIPPINES</span><span style="font-size: large;"><o:p></o:p></span></span></span></b></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">BACKGROUND</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Philippines has maintained the HIV prevalence among the general
population at less than 1%, albeit there has been a 203% increase in the
estimated new HIV infections from 2010 to 2018. Progress in achieving
prevention targets has been slow, as indicated by low condom use and low
comprehensive knowledge of HIV prevention and transmission among key
populations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In 2015, the World Health Organization (WHO) recommended the use of
daily oral pre–exposure prophylaxis (PrEP) using a two–drug combination of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7163232/" target="_blank">tenofovir</a> and <a href="https://medlineplus.gov/druginfo/meds/a612036.html">emtricitabine</a> as an additional option for
people at substantial risk of HIV infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="font-size: large;"><span style="color: #01ffff;">In 2017, The Love Yourself, with support from the Department of Health
through the Research Institute for Tropical Medicine and the Global Fund
Project, has implemented the 24–month demonstration study that examined
community–based delivery of HIV PrEP for males have sex with males (MSM) and
transgender women (TGW) at high risk for HIV infection. </span><span style="color: #fcff01;">Among the 250 enrolled in the PrEP, no new cases of HIV infection detected,
and no side effects reported. There was no increase in diagnoses of
sexually transmitted infections (STI) over time. The zero HIV infection outcome
of the project provides additional evidence for scaling–up PrEP.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In 2019, the WHO updated its guidelines to include event–driven PrEP
which offers flexibility, choice, and convenience to MSM and has the potential
to reduce the cost of drugs, pill burden and toxicity, and improve continuation
among those who find daily pill–taking challenging. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">OBJECTIVE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The interim guidelines provide details on the delivery of pre–exposure
prophylaxis (PrEP) services for people at substantial risk of HIV infection. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SCOPE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">These guidelines are intended for use by STI and HIV service providers,
coordinators, heads, or managers of facilities with HIV services, community–based organizations, and other facilities offering PrEP services from public
and private sectors. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">DEFINITION OF TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">ARS (Acute retroviral syndrome)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – is a condition that may develop as early as 2 to 4 weeks after
someone contract HIV. Possibility of ARS is considered if there are flu–like
signs and symptoms such as sore throat, swollen lymph glands, and body aches,
and the client reports condomless sex in the past 14 days.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Daily Oral PrEP</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – requires take
a single pill of tenofovir (TDF) / emtricitabine (FTC) daily and dosing regimen
is appropriate for all people, irrespective of gender, sexual orientation, or
risk behavior.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Event–driven PrEP (ED PrEP)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – is a
dosing regimen recommended only for MSM and consists of a double dose (two
pills) of TDF/FTC, which serves as the loading dose, taken between two and 24
hours in advance of sex; then a third pill is taken 24 hours after the first
two pills, and a fourth pill 48 hours after the first two pills.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Pre–exposure prophylaxis (<a href="https://www.cdc.gov/hiv/basics/prep.html" target="_blank">PrEP</a>)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – is the use of antiretroviral (ARV) drugs by people to prevent
contracting HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Sero–conversion</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – is the change
from a seronegative to a seropositive HIV status.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo2; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">GENERAL GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l22 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Information on combination prevention from risk reduction behaviors,
correct and consistent condom sue with water–based lubricants, availability,
and access of pre–exposure prophylaxis (PrEP) shall be included in the package
of HIV prevention services for key populations (KP) at substantial risk of HIV
infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l22 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All HIV health service providers including partners from other
government and private health facilities and community–based organizations shall
be engaged to improve knowledge, awareness of, and demand for PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l22 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Government and donor procured PrEP shall be managed by the DOH and made
available through the Centers for Health Development (CHD) in Social Hygiene
Clinics, Primary HIV care clinics, HIV treatment hubs, including select
community centers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l22 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Referral of client for PrEP and other HIV combination prevention
services shall be enhanced, including those who test HIV negative after partner
testing or self–screening.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l22 level1 lfo3; text-indent: -18.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SPECIFIC GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l24 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Programmatic requirements for PrEP service provision</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Human resource to provide counseling, screening, and follow–up
monitoring.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Access to clinicians for scripting and initiation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Access to laboratory service for baseline testing and monitoring.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Commodity management procedures to order, handling and requesting.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Monitoring and evaluation systems including documentation, quality
assurance, and improvement, and reporting.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l24 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Screening for substantial risk of HIV infection</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Individuals at substantial risk for HIV infection who will benefit most
from PrEP:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Those who engage in sex with a PLHIV who is not virally suppressed or
whose results of viral load testing are unknown (e.g., HIV serodiscordant
couples).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Those having condomless or unprotected anal/vaginal or neovaginal sex in
the past 6 months with more than one partner. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Those with history of STI in the past 6 months (diagnosed, symptoms, or
self–report).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Those using sex–enhancing drugs or non–sterile injecting equipment in
the past 6 months.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Those who have used HIV post–exposure prophylaxis (PEP) for sexual
exposure in the past six months.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Those who have a sexual partner with one or more HIV risk factors in the
past 6 months.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Those who requested PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Clinical Indications:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Must be HIV negative.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Must be free of signs/symptoms of an acute retroviral syndrome (ARS)
with no probable recent exposure to HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Must have a good renal function, if known (creatinine clearance >60 ml/min).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Must be free of any allergy or contraindications to PrEP medicines (TDF
or FTC).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Must weigh at least 35 kg.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">PrEP has no or minimal drug interactions with commonly prescribed
medicines nor significant side effects. PrEP can be used safely by most people,
including pregnant or breastfeeding women, women using hormonal drugs for
contraception, or transgender persons on gender–affirmative hormone therapy.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l24 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Initiation of PrEP</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Pre–initiation counseling on PrEP shall focus on ensuring understanding
of PrEP as an additional prevention method and helping the client to decide
whether PrEP is the right prevention tool. (Please see Annex 1 at </span><a href="https://bit.ly/prepannex"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">https://bit.ly/prepannex</span></a><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All clients eligible and indicating interest in PrEp need to undergo the
following essential diagnostic/laboratory tests and clinical assessment and
evaluation:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV screening/testing within 7 days before PrEP initiation</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l13 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Clients reactive to HIV screening should be immediately linked to care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l13 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">If there is a history of recent HIV exposure (in the past 72 hours),
consider PEP and re–test after 28 days. Complete a symptom checklist for
possible acute HIV infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l13 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">After 28 days of PEP, PrEP can be started without a gap if the HIV test
remains negative, and there is a substantial ongoing risk of HIV acquisition.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l13 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">For persons with constant potential exposure to HIV, there should be no
gap between finishing PEP and starting PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Serum Creatinine Test. Availability of Serum Creatinine test result
should not delay PrEp initiation unless there is clinical suspicion of poor
renal function or pre–existing renal disease.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HBsAg test done within 30 days prior to PrEP initiation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l21 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">If the result is negative, recommend hepatitis B vaccination.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l21 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">If the result is positive, manage Hepatitis B per DM 2019 – 0465 (</span><a href="http://bit.ly/hepbforms"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">http://bit.ly/hepbforms</span></a><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">STI screening (syndromic management or etiological diagnosis)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Hepatitis C antibody screening for MSM and PWID.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Pregnancy assessment and testing for women and transgender men. PrEP can
safely continue throughout pregnancy unless the client chooses to stop.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Dosing Regimen</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide PrEP on the same day to HIV negative individuals without
contraindications, while laboratory tests (creatinine, HBsAg) are sent for
testing. Contact the PrEP user if test results require additional confirmation
or treatment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Prescribe PrEP for one–month supply at first visit, the two month’s
supply at second visit, and three month’s supply thereafter. Based on
compliance and other circumstances, more than 3 month’s supply can be
prescribed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Daily Oral PrEP shall be used during periods of frequent sex or when sex
is unpredictable. Anyone who meets the indications shall take Daily Oral PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Dosing or Daily Oral PrEP using oral formulation of TDF/FTC shall be
once a day, with or without food.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Maximum dose is two tablets per day.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Everyone who is starting or restarting PrEP, will need to take five to
seven days (for anal intercourse) or twenty days (for vaginal intercourse) of
daily intake of PrEP before achieving protection against HIV infection.
Additional HIV prevention measures should thus be taken during this period.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">For MSM (whose only risk is through anal sex) who is starting or
restarting on PrEP, should start with a double dose of TDF/FTC (two pills), 2 –
24 hours before having sex.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Except for MSM, PrEP users can stop 28 days after the last possible HIV
exposure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">For MSM (whose only risk is through anal sex), PrEP discontinuation may
be done by taking a pill once a day for two days after the last possible HIV
exposure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Event–driven PrEP can be considered for infrequent, anticipated, or
planned sex.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l16 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Dosing for ED–PrEP (for MSM only) using oral formulation of TDF /FTC
shall be two pills as loading dose between 2 and 24 hours before sex; then a
third pill taken 24 hours after the first two pills; and a fourth pill 48 hours
after the first two pills (please see Annex 2 at </span><a href="https://bit.ly/prepannex"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">https://bit.ly/prepannex</span></a><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l16 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">If more sex acts take place over the following days, a single PrEP pill
can be continued daily for as long as sex continues, with a single daily pill
taken for each of two days after the last sext act.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">In consultation with the clinician, MSM can switch between daily and
ED–PrEP based on changes in their sexual practices. (Please see Annex 3A and 3B
at </span><a href="https://bit.ly/prepannex"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">https://bit.ly/prepannex</span></a><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Clients with recent risk/exposure need to take two doses of PrEP at the
regular time for another 48 hours, one on each of the two days after client’s
last risk.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l24 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Stopping PrEP</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">People can consider stopping PrEP if they are no longer at a substantial
risk of acquiring HIV infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Clients should consult a clinician whenever there’s a decision to stop
PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l24 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Clinical follow–up and monitoring</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Clinicians may want to see their clients after one month for HIV re–testing, assessing early side effects, drug dispensing and adherence
evaluation, and addressing any questions or difficulties.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Follow up HIV screening to monitor status shall be scheduled after 1
month of PrEP and at least every 3 months thereafter.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l5 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Assess for signs and symptoms of acute HIV infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l5 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Individuals with an HIV–inconclusive status should stop PrEP and be
retested after 14 days. The client may resume PrEP if the repeat test is
negative.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l5 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">In HIV seroconversion, stop PrEP, and rapidly link client to care.
Receiving HIV treatment facility shall initiate treatment and secure a blood
specimen for HIV drug resistance testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Serum creatinine tests shall be done every 6 months or as indicated,
especially if there is a history of conditions affecting the kidney, such as
diabetes or hypertension. Discontinue PrEP if creatinine clearance falls below
60 ml/min.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">STI screening (syndromic management or etiological diagnosis) shall be
done at each follow–up or every 3 months and managed accordingly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">For Hepatitis C antibody screening, consider testing MSM and PWID every
12 months. If positive, refer to a Specialist for management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l24 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Follow–up Counseling for PrEP</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The following shall be emphasized during follow–up counseling:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">PrEP dosing and side effects assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Risks of sharing PrEP drugs with peers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Adherent assessment</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l11 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Number of days client is on continuous intake of PrEP at the time of
visit.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l11 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Number of days on PrEP before and after the last possible HIV exposure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Proper way to store PrEP medications.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Sexual health protection (condom use, pregnancy, STI, alcohol, substance
abuse).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Issues related to mental health (especially depression)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Intimate partner violence.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Include provision of commodities for prevention (condoms and lubricants)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Include reminder to consult the clinician whenever a decision is made to
stop PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l24 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Monitoring and Evaluation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Monitoring and Evaluation of PrEP implementation shall be measured by
specific indicators. Annexes 4 and 5 provide PrEP indicators.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Supportive supervision and mentorship uptake and use shall be done
semi–annually and on–demand to ensure continuous quality control and
improvement (CQI) at the facility and regional level.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All facilities offering PrEP shall maintain PrEP forms and submit
monthly report to the Epidemiology Bureau and Regional Epidemiology and
Surveillance Unit. (Please see Annexes 7 – 11 at </span><a href="https://bit.ly/prepannex"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">https://bit.ly/prepannex</span></a><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">).</span></span></p><p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo22; text-indent: -18.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">PROGRAMMATIC CONSIDRATIONS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The roll–out of PrEP shall follow a phased approach as summarized
below:;</span></span></p>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; margin-left: 36.0pt; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr>
<td style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 211.85pt;" valign="top" width="282">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Year 1<o:p></o:p></span></span></p>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.2pt;" valign="top" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Year 2<o:p></o:p></span></span></p>
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<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 3.0cm;" valign="top" width="113">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Year 3<o:p></o:p></span></span></p>
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<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 396.1pt;" valign="top" width="528">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">GEOGRAPHIC AREA <o:p></o:p></span></span></p>
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<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 211.85pt;" valign="top" width="282">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NCR, Central Visayas,
Central Luzon, and select Global Fund and PEPFAR Category A sites. Facilities
in other regions which have the capacity and interest to deliver PrEP
services <o:p></o:p></span></span></p>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.2pt;" valign="top" width="132">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">All other HIV category A
cities<o:p></o:p></span></span></p>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 3.0cm;" valign="top" width="113">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Nationwide <o:p></o:p></span></span></p>
</td>
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</tbody></table>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">ROLES AND RESPONSIBILITIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l23 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Disease Prevention and Control Bureau (DPCB)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Set general direction, develop policies, and allocate resources for PrEP
implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Convene the HIV sub–technical working group to regularly review the PrEP
Guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Coordinate the supply and distribution of donated PrEP drugs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l23 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Epidemiology Bureau </span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop and implement the PrEP monitoring and evaluation plan. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Manage, process, and provide PrEP data to the DPCB and relevant
partners.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l23 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Centers for Health Development (CHD)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Disseminate the guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide technical and logistical support to relevant facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Advocate to local government units for the availability of PrEP drugs
and related services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Strengthen service delivery network to ensure access to HIV services,
including PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct regular monitoring on the implementation of these guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l23 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Local Government Units (LGUs)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Institutionalize the implementation of these guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure provision of quality PrEP services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct quality management of PrEP services and monitoring of PrEP
implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure timely submission of reports and adherence to reporting
standards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l23 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Partners from public and private sector health facilities and community–
based organizations:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide PrEP services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure linkage of clients to HIV prevention services, including to PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct awareness and demand generation activities for PrEP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure timely submission of reports and adherence to reporting
standards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l23 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Development Partners</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l19 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Support PrEP implementation through provision of technical assistance,
augmentation of financial and logistical resources.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l19 level1 lfo29; text-indent: -18.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">FUNDING</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The National HIV, AIDS and STI Prevention and Control Program of the
DPCB and CHDs shall allocate budget to support the implementation of these
policies and guidelines, especially on capacity building, monitoring and
evaluation, and augmentation of PrEP drugs. In 2021 and 2022, PrEP Drugs shall
be sourced out from HIV projects and grants. The (LGUs may procure
FDA–registered PrEP drugs based on their respective annual operational plans. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l4 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">X.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Department Memorandum shall take effect immediately. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">MYRNA C. CABOTAJE, MD, MPH,
MPH, CESO III<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Undersecretary of Health <o:p></o:p></span></span></p>
<p><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">Public Health Services Team</span> </span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-1595667589610652322023-05-29T19:34:00.000+08:002023-05-29T19:34:24.514+08:00Administrative Order No. 2019 – 0001<p><span style="color: #01ffff; font-size: large;"> <span style="font-family: "Palatino Linotype", serif;">10
January 2019</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;"><span style="font-size: x-large;">GUIDELINES ON
THE IMPLEMENTATION OF RAPID HIV DIAGNOSTIC ALGORITHM (rHIVda)</span><span style="font-size: large;"><o:p></o:p></span></span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Philippines registered the fastest
growing HIV and AIDS epidemic in Asia Pacific in the past ten years. The
reported case of HIV has increased from one case per day in 2007 to 31 newly
diagnosed cases per day in 2017. Unprotected sex remains the leading mode of
transmission, with men having sex with comprising 83% of the number of new
cases. The HIV infection is also transmitted through male – female sex, needle
sharing among injecting drug users, and mother to child transmission.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Until 2015, the country is using Western
Blot test as part of the HIV Confirmatory algorithm. The average waiting time
of confirmatory test result is around seven to ten days but may reach up to
three weeks when referring laboratories pool their specimens before sending to the
National Reference Laboratory – San Lazaro Hospital / STD AIDS Cooperative
Central Laboratory (NRL – SLH/SACCL) to lessen the courier service expenses.
The long waiting period of confirmatory test leads to delay in HIV treatment
initiation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">With increasing trend of HIV cases,
there is a need for early recognition of HIV cases. In low prevalence
countries, WHO recommends testing algorithms of sequential combinations of two
or three tests (immunoassay and/or rapid tests) which can be reliably used to
rapidly confirm HIV infection. Thus, the introduction of Rapid Diagnostic Tests
(RDT) in other countries has become an important strategy to increase access to
HIV testing, reduce long waiting time for laboratory results, reduce
undiagnosed cases, prevent HIV transmission, and provide immediate HIV Testing
Services (HTS) to prolong and improve quality of life of People Living with HIV
(PLHIV).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Hence, the National HIV, AIDS and STI
Prevention and Control Program (NASPCP) is introducing the use of rapid HIV diagnostic
algorithms (rHIVda) as the new HIV confirmatory test in the Philippines. This
issuance is adopting the HIV diagnostic algorithm validated and piloted in
eight sites around the country as a collaborative work of the Department of
Health – Disease Prevention and Control Bureau (DOH (DPCB), World Health
Organization (WHO), and National Reference Laboratory – San Lazaro Hospital /
STD AIDS Cooperative Central Laboratory (NRL) – Australia in 2014 to 2015.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l28 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">General
Objective:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To provide implementation policies and
guidelines for the use of rapid HIV diagnostic algorithm (rHIVda) as the new
HIV confirmatory test in Certified rHIVda Confirmatory Laboratory (CrCL)
facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l28 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Specific
Objective:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
provide standards for the establishment of CrCL. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
outline the operational guidelines for rHIVda. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
outline the roles and responsibilities of different DOH units and other
stakeholders.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SCOPE AND
COVERAGE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This policy shall cover Social Hygiene Clinics
and HIV testing laboratories except Medical Facilities for Overseas Workers and
Seafarers (MFOWS). The rHIVda is intended to be used in both general and key
HIV populations. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF
TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Certified
rHIVda Confirmatory Laboratory (CrCL)</span></b><span style="font-family: "Palatino Linotype", serif;"> – a DOH–licensed clinical laboratory
compliant with rapid HIV diagnostic algorithms (rHIVda) laboratory standards
and technical requirements set by the National HIV, AIDS and STI Prevention and
Control Program (NASPCP) and National Reference Laboratory – San Lazaro
Hospital / STI, AIDS Central Cooperative Laboratory (NRL – SLH / SACCL).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
Laboratory</span></b><span style="font-family: "Palatino Linotype", serif;">
– a facility where tests are done on specimens from human body to obtain
information about the health status of a patient for the prevention, diagnosis,
and treatment of diseases. These includes, but not limited to, the following
disciplines: Clinical Chemistry, Hematology, Immunohematology, Microbiology,
Immunology, Clinical Microscopy, Histopathology, Cytology, Toxicology,
Endocrinology, Molecular Biology and Cytogenetics. Other functions of the
clinical laboratory are to provide consultative advisory services covering all
aspects of laboratory investigation including the interpretation of results and
advice on further appropriate investigation. Facilities that are involved in
the pre –analytical processes, such as collection, handling and preparation of
specimens, or act as mailing or distribution center, such as in a laboratory
network or system are also considered to be a part of a clinical laboratory. The
total testing process includes pre–analytical, analytical, and post analytical
procedures (DOH <a href="https://mt-lectures.blogspot.com/2017/08/administrative-order-no-2007-0027.html" target="_blank">A.O. No. 2007 – 0027</a>)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Enhanced
HIV/ AIDS and ART Registry of the Philippines (eHARP)</span></b><span style="font-family: "Palatino Linotype", serif;"> – an electronic
case–based reporting and database system maintained by the Epidemiology Bureau
for reporting use of HIV treatment hubs, primary HIV care facilities, and CrCL
facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to initial serological test to determine the presence of antigens
and/or antibodies against HIV, performed by a HIV–proficient medical
technologist (<a href="https://mt-lectures.blogspot.com/2023/05/administrative-order-no-2017-0019.html" target="_blank">A.O. No. 2017 – 0019</a>)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing Services (HTS)</span></b><span style="font-family: "Palatino Linotype", serif;"> – full range of services accompanying HIV testing
including counselling (pre–HIV test and post–HIV test); linkage to appropriate
HIV prevention, treatment and care services and other clinical and support
services with proper coordination with reference laboratories to support
quality assurance and delivery of accurate results (A.O. No. 2017 – 0019).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing Services (HTS) facility</span></b><span style="font-family: "Palatino Linotype", serif;"> – any health facility providing HIV
testing services. This can offer stand–alone HTS or incorporated into existing
healthcare support services to People Living with HIV (PLHIV) including but not
limited to HIV testing services, clinical management, patient monitoring, and
other care and support services. Antiretroviral (ARV) treatment can be accessed
through these facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Key
population</span></b><span style="font-family: "Palatino Linotype", serif;">
– members of this population are males who are having sex with males, people in
prisons and other closed settings, people who inject drugs, sex workers, and
transgender men and women (A.O. No. 2017 – 0019).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Non–certified
rHIVda Confirmatory Laboratory (Non–CrCL)</span></b><span style="font-family: "Palatino Linotype", serif;"> – a clinical laboratory where
HIV screening test is performed but is unauthorized to perform HIV confirmatory
test (i.e., rHIVda, Western Blot or PCR).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Non–reactive
Result</span></b><span style="font-family: "Palatino Linotype", serif;">
– when an HIV testing or screening procedure indicates absences of HIV
antibodies and/or antigens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Quality
Assurance (QA)</span></b><span style="font-family: "Palatino Linotype", serif;">
– a planned, and systematic intervention done by testing laboratories that aims
to ensure that their services and processes will satisfy given requirements for
quality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Quality
Management System (QMS)</span></b><span style="font-family: "Palatino Linotype", serif;"> – a comprehensive and integrated organizational
approach that provides guidance and support to achieve quality in all
components of HIV testing using rHIVda.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">12.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Rapid
HIV diagnostic algorithms (rHIVda)</span></b><span style="font-family: "Palatino Linotype", serif;"> – uses a combination of 2 or 3 rapid test
formats done in parallel or sequence on a sample that had a reactive result in
the initial test (A.O. NO. 2017 – 0019).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">13.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Reactive
result</span></b><span style="font-family: "Palatino Linotype", serif;">
– when an HIV testing or screening procedure indicates presence of HIV
antibodies and/or antigens. This result should be confirmed using the current
diagnostic algorithm.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">14.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Regional
Laboratory Quality Officer</span></b><span style="font-family: "Palatino Linotype", serif;"> – a dedicated DOH – Center for Health Development
(CHD) personnel to monitor and provide technical support CrCL in compliance
with laboratory standards and technical requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">15.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Social
Hygiene Clinics</span></b><span style="font-family: "Palatino Linotype", serif;">
– these are clinics of local government unit (LGU) that specialize in the
management of Sexually Transmitted Infections (A.O. No. 2017 – 0019).</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Disease Prevention and Control Bureau (DPCB shall provide overall direction in
the nationwide implementation of rHIVda as confirmatory test for HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
rHIVda shall be a combination of three WHO prequalified and FDA registered HIV
Rapid Diagnostic Tests (RDT).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
rHIVda shall be established in government clinical laboratories, HIV Treatment
Hubs, Social Hygiene Clinics (SHC), HIV Testing Services (HTS) facilities,
private and project–based HIV clinics that passed the laboratory standards and
technical requirements of a Certified rHIVda Confirmatory Laboratory (CrCL).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Only
DOH–licensed and Certified rHIVda Confirmatory Laboratory is allowed to issue
an official confirmatory result based on rHIVda algorithm.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Confirmatory
test results released by CrCL shall be acknowledged for PhilHealth Out–Patient
HIV and AIDS Treatment (OHAT) package enrolment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Quality
Assurance Program for rHIVda shall include, but not limited to lot testing,
National External Quality Assurance (NEQAS), and validation, monitoring, and
supervision to ensure correct laboratory testing and diagnosis, appropriate
management of specimens, recording and releasing of results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Strong
collaboration with LGU shall be developed to ensure compliance of CrCL to
laboratory standards and sustain its operations. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establishment
of Certified rHIVda Confirmatory Laboratory (CrCL)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Any
public clinical laboratories interested to establish a CrCL shall submit a Letter
of Intent to DOH Regional Director.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Areas
with high prevalence of HIV and HTS facilities initially supported by <a href="https://www.theglobalfund.org/media/1467/replenishment_2013newfundingmodel_report_en.pdf" target="_blank">Global Fund Project – New Funding Model (NFM)</a> shall
prioritize in the establishment of CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
certificate “Certified rHIVda Confirmatory Laboratory (CrCL)” shall be issued
by NRL – SLH/SACCL or its regional counterpart to a public clinical laboratory
which met rHIVda laboratory standards and technical requirements. The CrCL
certificate is a pre–requisite for the issuance of LTO, which is valid for 2
years, by HFSRB or Centers for Health Development – Regulatory, Licensing and
Enforcement Division (CHD – RLED).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
laboratory with existing LTO, rHIVda shall be applied as additional service to
existing DOH – LTO.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
laboratory without existing DOH – LTO, it shall receive a CrCl certificate from
SACCL before it can apply to DOH for LTO as laboratory with limited capacity.
(Refer to A.O. 2007 – 0027, Revised Rules and
Regulations Governing the Licensure and Regulation of Clinical Laboratories in
the Philippines).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Clinical
Laboratories which need technical assistance to meet requirements for
certification shall be supported by the CHD – HIV/STI Program and/or the
designated Quality Laboratory Officer.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Licensing
of CrCL shall be under the responsibility of the Health Facilities and Service
Regulatory Bureau (HFSRB) as defined in Administrative Order No. 2018 – 0016 or
the Revised Guidelines in the Implementation of the One–Stop Shop Licensing
System.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Capability–building</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l29 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="font-size: large;"><span style="color: #01ffff; font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;">For
the first 2 years of implementation, training, on rHIVda for </span><span style="color: #fcff01;">Medical Technologists</span> <span style="color: #01ffff;">of CrCL shall be provided by the
NRL – SLH/SACCL.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l29 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NRL shall accredit training institutions to provide accessible and sustainable
HIV proficiency training for medical Medical Technologists
in different regions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l29 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
pool of trainers shall be established by NRL – SLH/SACCL to cascade rHIVda
training and provide continuing technical support to CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Human
Resource</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l24 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="font-size: large;"><span style="color: #01ffff; font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;">HIV
proficiency certification shall be required to any </span><span style="color: #fcff01;">Medical
Technologists</span><span style="color: #01ffff;"> who will perform rHIVda.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l24 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="font-size: large;"><span style="color: #01ffff; font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;">There
shall be adequate number of </span><span style="color: #fcff01;">Medical Technologists</span><span style="color: #01ffff;">
in a CrCL. </span><span style="color: #fcff01;">The standard number of medical technologists
shall be based on the ratio of one medical technologist to manually perform 50
laboratory test per eight hours. Additional staff depends on workload (10
minutes/test)</span><span style="color: #01ffff;">. (Refer to A.O. No. 2007 – 0027).</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Laboratory
Testing</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l27 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
rHIVda algorithm shall be done in sequence of three WHO pre–qualified and FDA
registered Rapid Diagnostic Tests (RDTs) pre–selected by NRL – SLH/ SACCL in
coordination with NASPCP.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l27 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Test
0 (T0) reactive blood specimens from Non–CrCL shall be sent to CrCL for
confirmatory test along with the Laboratory Request Form for HIV Testing (See
Annex 4). Only reactive blood specimen referred from Non–CrCL facility shall be
accepted by CrCL facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l27 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Walk–in
clients in CrCl facility without T0 result shall tested using rHIVda Test 1
(T1). If T1 result is non–reactive, release result as non–reactive. If T1
result is reactive, test specimen using rHIVda Test 2 (T2). If T2 result is
reactive, test specimen using rHIVda Test 3 (T3). If T3 result is reactive, release
result as HIV positive.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l27 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Clients
with T0 reactive results from Non–CrCL facility shall be tested using rHIVda
Test one (T1). If T1 result is reactive, test specimen using rHIVda test 2
(T2). If T2 result is reactive, test specimen using rHIVda Test 3 (T3). If T3
result is reactive, release result as HIV positive.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l27 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
rHIVda result is Inconclusive or there is any inconsistency with T1, T2 and T3
results, follow recommendations in Annex 1. Interpretation and release of
Inconclusive Results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Interpretation
and Release of Result</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><b><span style="font-family: "Palatino Linotype", serif;">HIV
POSITIVE</span></b><span style="font-family: "Palatino Linotype", serif;">
result shall be released if three rHIVda results are all reactive (T1+, T2+,
T3+).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><b><span style="font-family: "Palatino Linotype", serif;">HIV
NEGATIVE</span></b><span style="font-family: "Palatino Linotype", serif;">
result shall be released if the following conditions are satisfied:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l5 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">T0
test is not done and T1 result is non–reactive for walk–in clients in CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l5 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
repeated T1 is non–reactive for second time (Two T1 non–reactive results).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><b><span style="font-family: "Palatino Linotype", serif;">HIV
INCONCLUSIVE</span></b><span style="font-family: "Palatino Linotype", serif;">
result shall be reported if there is any inconsistency with screening and/or
rHIVda RDT results. Combinations are as follows:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">T0
results is reactive, T1 result is non–reactive (T0+, T1–)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">T1
result is reactive, T2 result is non–reactive (T1+, T2–)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">T1
result is reactive, T2 result is reactive, T3 result is non–reactive (T1+, T2+,
T3–)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="font-size: large;"><span style="color: #01ffff; font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;">The
confirmatory test result released by CrCL shall be signed by </span><span style="color: #fcff01;">HIV–proficient Medical Technologists</span> <span style="color: #01ffff;">and Pathologist.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
results shall be released to client during post–test counselling sessions.
(Refer to A.O. No. 2017 – 0019)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Data
Management</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
CrCL shall have a designated data management point person.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
rHIVda–related processes must be properly documented and recorded, including
errors and gaps in the processes in the laboratory workbook/registry.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
CrCL shall maintain daily client registry and shall submit monthly monitoring
report to NASPC Coordinator of their respective LGU every Friday of the month.
These collected reports shall be submitted by the DOH Regional Coordinator to
the Disease Prevention and Control Bureau (DPCB) every three months.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
CrCL shall report all rHIVda clients’ data to the Epidemiology Bureau using the
eHARP software. (See Forms in Annex 2 and 3).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Quality
Assurance</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Lot
Testing</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l8 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NRL – SLH/SACCL shall subject samples per lot number of rHIVda RDTs to evaluation
prior to shipment to CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l8 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Consolidated
report shall be submitted by NRL to DPCB every lot number tested.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">National
External Quality Assessment Scheme (NEQAS)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l12 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
CrCL shall participate in the annual National External Quality Assessment
Scheme (NEQAS) implemented by NRL – SLH/SACCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l12 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
CrCL passing the NEQAS shall receive certificate valid for 1 year.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l12 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
CrCL that will not pass the NEQAS shall be subjected to onsite assessment,
retraining and close monitoring of performance until all recommendations are
satisfactory met; and/or cancellation of CrCl certificate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l12 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">An
annual report on NEQAS shall be submitted by NRL to DPCB and HFSRB, to be used
as reference in renewing DOH – LTO of clinical laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Monitoring
and Supervision</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
CrCL shall comply with Quality Management System (QMS)
policies and procedures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitoring
of the CrCL performance shall be assessed regularly by the Quality Assessment
Team composed of NRL – SLH/SACL, CHD and/or DOH Central Office – HIV Program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Technical
laboratory supervision shall be provided as necessary or upon CrCL request.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Monitoring
and Evaluation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Program
performance indicators shall be used as basis for the conduct of monitoring and
evaluation activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitoring
of rHIVda programmatic outcomes shall be covered by the annual Health Sector
Strategic Plan for HIV of the NASPCP.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo19; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">ROLES AND
RESPONSIBILITIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Disease
Prevention and Control Bureau (DPCB)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Together
with NRL – SLH/SACCL, develop standards and technical requirements for a CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Endorse
the list of potential CrCL laboratories to NRL – SLH/SACCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Oversee
the creation of rHIVda pool of trainers to implement decentralize training and
other capability building activities for health workers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
rHIVda commodities to government CrCL through CHD.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Support
NRL – SLH/SACCL in preparation of budget proposal in the implementation of
rHIVda and NEQAS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Collaborate
with the National Voluntary Blood Donation Safety
Program (NVBSP) to provide constant supply of blood for NEQAS
implementation in the CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
health promotion and advocacy activity for rHIVda service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
monitoring, supervision, and evaluation activities of rHIVda implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Epidemiology
Bureau (EB)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l23 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Integrate
rHIVda reporting in the current HIV surveillance system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l23 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
training on Data Management and Encoding for rHIVda.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l23 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
all CrCl submission of reports to HIV surveillance system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l23 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
HIV surveillance report to DPCB.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Health
Facilities and Services Regulatory Bureau (HFSRB)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Set
minimum licensing standards for HIV testing laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Issue
License to Operate (LTO) to compliant laboratories applying for rHIVda.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Disseminate
regulatory policies and standards for information and compliance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
list of licensed CrCL sites to PhilHealth and DPCB.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">National
Reference Laboratory – San Lazaro Hospital – STD AIDS Cooperative Central
Laboratory (NRL – SLH/SACCL)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assess
and certify clinical laboratories and clinics as “Certified rHIVda Clinical
Laboratory (CrCL)” based on certification requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Validate
inconsistent rHIVda results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop
Proficiency Training Program, training modules, monitoring, and supervision
tools for pool of trainers pursuant to the implementation of this guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Continually
assess diagnostic kits with potential use for rHIVda and shall provide updated
list of in – vitro diagnostic kits and combination of rapid tests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
Proficiency Training and certificates to Medical
Technologists and rHIVda trainers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
technical assistance, mentorship, and supervision to CrCl in the development of
site standard operating procedures (SOPs), job aids (work instructions) and
internal quality assurance procedures. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Oversee
the implementation of Quality Assurance Program (QAP) together with NASPCP and
CHD.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
regular National External Quality Assurance Scheme (NEQAS).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
list of certified facilities to HFSRB and DOH – RLED regularly for validation
of certificates submitted by the facility when they apply for LTO.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Provide
feedback and recommendations on the performance of CrCL to NASPCP regularly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Center
for Health Development (CHD) – HIV/STI Program</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
and disseminate rHIVda guidelines to HIV stakeholders and partners.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Lobby
with Local Chief Executives (LCEs) in setting up CrCL in identified areas with
high prevalence of HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Endorse
to Disease Prevention and Control Bureau (DPCB) the list of potential CrCL
facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Support
the compliance of CrCl to required technical and standard requirements /
Quality Management Systems of rHIVda laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Designate
Regional Quality Officer and provide support and technical assistance to
clinical laboratories and facilities to ensure readiness to comply with
laboratory standards and technical requirements in establishing CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Lead
the creation of rHIVda pool of trainers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Together
with NRL – SLH/SACCL, organize training, mentoring and coaching activities for
CrCL health workers following NASPCP policies and direction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
rHIVda testing kits and other consumables to CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
monitoring, supervision, and evaluation activities of rHIVda implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l2 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Regularly
collect and analyze regional supply inventory reports, monitoring, and
supervision reports, and provide feedback to DPCB.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">PhilHealth</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l22 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Inform
and provide list of accredited CrCL facilities for OHAT claims.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l22 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
with HFSRB for regular updates of CrCl list.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
Hospitals and HIV Treatment Hubs</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish
CrCL in their respective laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Accept
and manage clients with HIV positive results from CrCl and/or NRL – SLH/SACCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Local
Government Units</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Support
the establishment and maintenance of CrCL in their respective areas, including
but not limited to, provision of laboratory space, additional funds for hiring
of human resource, additional commodities, and other logistical needs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Institutionalize
the implementation of rHIVda in HIV testing facilities in their area of
jurisdiction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Support
CrCL to comply with standards and requirements for rHIVda.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l20 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Certified
rHIVda Confirmatory Laboratories (CrCL)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Release
accurate laboratory result on the same day the specimen is received.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
confidentiality of laboratory results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop,
update, sustain and strictly implement standard operating procedures (SOP), job
aids (work instructions), and Quality Management System (QMS) for a CrCL
facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish
and maintain good coordination with CHD, NRL – SLH/SACCL, HIV testing and
treatment facilities, LGU, CBO, NGO and other agencies to facilitate efficient
rHIVda implementation and service delivery.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Participate
in NEQAS by NRL – SLH/SACCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Advocate
for logistical and human resource supports for rHIVda.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
reports to CHD and DOH – Epidemiology Bureau.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo29; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">FUNDING</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The DOH – DPCB shall allocate budget for
the implementation of these guidelines, including but not limited to,
augmentation of rHIVda test kits and consumable, conduct of capacity building
activities, monitoring, supervision, and evaluation activities. The Local
Government Units (LGU) shall be tapped to provide financial support for the
implementation of these guidelines that shall be included in their respective
annual budgets.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Provisions in previous issuances
inconsistent and contrary to this Administrative Order are hereby rescinded and
repealed.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l14 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">X.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY
CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Administrative Order shall take
effect immediately. All implementing agencies are required to strictly follow
this directive.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO
T. DUQUE, III, MD, MSc. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary
of Health</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="text-align: left;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX 1:
INTERPRETATION AND RELEASE OF INCONCLUSIVE RESULTS</span></span></b></p>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">TEST RESULT IN
CrCL<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">INTERPRETATION
OF HIV STATUS<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" width="158">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">RECOMMENDATION<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">REMARKS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l25 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">T1
Non–Reactive <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inconclusive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Repeat
rHIVda after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(Send
specimen to SACCL for data collection) <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To
come back after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Same result
after Return 1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Negative<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">–
release negative result <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(Send
specimen to SACCL for data collection)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Post
– test counselling <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l25 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">T1
Reactive / <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">T2 Non–Reactive <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inconclusive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Repeat
rHIVda after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(Send
specimen to SACCL for data collection)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To
come back after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Same result
after Return 1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inconclusive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Repeat
rHIVda after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(Send
specimen to SACCL for data collection)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To
come back after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Same result
after Return 2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inconclusive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Request
final result from SACCL <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(Send
specimen to SACCL for data collection)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Release
final result from SACCL <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l25 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">T1
Reactive <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">T2 Reactive <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">T3 Non–Reactive <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inconclusive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Repeat
rHIVda after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(Send
specimen to SACCL for data collection)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To
come back after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Same result
after Return 1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inconclusive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Repeat
rHIVda after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(Send
specimen to SACCL for data collection)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To
come back after <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
– 6 weeks<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 120.25pt;" width="160">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Same result
after Return 2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.25pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inconclusive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 118.6pt;" valign="top" width="158">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Request
final result from SACCL<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 112.7pt;" width="150">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Release
final result from SACCL <o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-5028275946321706612023-05-29T18:36:00.000+08:002023-05-29T18:36:44.763+08:00Administrative Order No. 2017 – 0019<p><span style="color: #01ffff; font-size: large;"> </span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">15
September 2017 <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><o:p> </o:p></span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: x-large;"><b><span style="font-family: "Palatino Linotype", serif;">POLICIES AND
GUIDELINES IN THE CONDUCT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) TESTING
SERVICES (HTS) </span></b><b><span style="font-family: "Palatino Linotype", serif;">IN HEALTH
FACILITIES</span></b></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Since 1984, over 39,622 cases of Human
Immunodeficiency Virus (HIV) infections have been reported in Philippines. Eighty
five percent (85%) of the total cases (33, 607) were reported in the past five
years, from January 2011 to December 2016 (Epidemiology Bureau, HIV, AIDS, and
ART Registry of the Philippines, 2016). The unprecedented increase in incidence
prompted the Department of Health (DOH) to intensify its prevention and control
initiatives in key populations and vulnerable groups by including HIV as one of
the 12 Legacy Agenda under the current DOH administration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Sixth AIDS Medium Term Plan (2017 –
2022) recognized HIV counselling and testing strategy as one of the preventive
interventions for key population at risk. HIV testing is being promoted to the
key population because through this intervention, those who have HIV risks are
given the opportunity to know their HIV status, and at the same time are
provided with information on risk reduction strategies and referred to relevant
support facilities. Providing counselling prior to and after HIV testing is
mandated by <a href="http://mt-lectures.blogspot.com/2017/08/republic-act-no-8504.html" target="_blank">Republic Act No. 8504</a>, “AIDS
Prevention and Control Act of 1998.”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The policy on HIV Counselling and
Testing is updated to provide quality standards in the conduct of HIV testing
services consistent with the 2015 WHO Consolidated Guidelines on HIV Testing
Services. This is also to ensure wider access to HIV Treatment in the country. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">General:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To provide policies and guidelines in
the conduct of HIV Testing Services (HTS) in health facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Specific
Objectives:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l32 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
identify the components of HTS and the protocol for each of them. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l32 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
set the standards/requirements for an HTS facility.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l32 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
define the roles and responsibilities of stakeholders in the implementation of
these guidelines.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l32 level1 lfo3; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SCOPE AND
COVERAGE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">These guidelines cover all STI and HIV
service providers, coordinators, managers of HIV clinics and/or testing
laboratories, and all facilities offering HIV testing for diagnostic purposes,
in both public and private settings. These guidelines do not include HIV
testing for purposes of surveillance, blood donation and research–related
activities.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF
TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Community–based
HIV screening (CBS) –</span></b><span style="font-family: "Palatino Linotype", serif;">
non–laboratory rapid HIV screening procedure done outside a health facility by
a trained member of community–based organizations or groups.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Confidentiality</span></b><span style="font-family: "Palatino Linotype", serif;"> – an ethical
duty that maintains the privacy of any personal information revealed during the
entire process of HIV Testing Services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Confirmed
HIV Positive Test Result</span></b><span style="font-family: "Palatino Linotype", serif;"> – a series of reactive test using rapid HIV
diagnostic algorithm (rHIVda), or Western Blot or Nucleic Amplification Test
(NAT) as performed by the National Reference Laboratory / San Lazaro Hospital
STD, AIDS Cooperative Central Laboratory (NRL/SLH SACCL) or any of the DOH
certified laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Consent</span></b><span style="font-family: "Palatino Linotype", serif;"> – written
informed decision of a person based on full information allowing him/her to
undergo HIV testing or a verbal decision to go through screening procedures.
The information shall be given by a healthcare provider or a HIV counsellor.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Counsellor</span></b><span style="font-family: "Palatino Linotype", serif;">
– a person who conducts counselling for HIV testing. He could be healthcare
provider or a DOH certified HIV Counsellor.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Counselling</span></b><span style="font-family: "Palatino Linotype", serif;">
– a confidential interactive communication process between a person and HIV
counsellor that enables a client to make an informed choice about being tested
for HIV and assist a client understand and cope with HIV test result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Screening</span></b><span style="font-family: "Palatino Linotype", serif;">
– a procedure using DOH Food and Drug Administration (FDA)–registered HIV test
kits performed through finger–pricking by a trained and supervised healthcare
worker and lay person.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to initial serological test to determine the presence of antigens and/or
antibodies against HIV, performed by a HIV–Proficient Medical Technologist.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing Services (HTS)</span></b><span style="font-family: "Palatino Linotype", serif;"> – full range of services accompanying HIV testing
including counselling (pre–HIV test and post–HIV test); linkage to appropriate
HIV prevention, treatment and care services and other clinical and support
services with proper coordination with reference laboratories to support
quality assurance and delivery of accurate results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing Services (HTS) facility</span></b><span style="font-family: "Palatino Linotype", serif;"> – any health facility (clinic hospitals)
providing HIV testing services which can be a stand–alone or incorporated into
existing healthcare services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Treatment Hub</span></b><span style="font-family: "Palatino Linotype", serif;">
– a hospital with an organized HIV and AIDS Core Team (HACT) that facilitates
in–patient and out–patient prevention, treatment, care, and support services.
Antiretroviral (ARV) treatment can be accessed through these facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">12.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Key
Population</span></b><span style="font-family: "Palatino Linotype", serif;">
– members of this population are male who are having sex with male, people in
prisons and other closed settings, people who inject drugs, sex workers, and
transgender men and women.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">13.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Quality
Assurance (QA)</span></b><span style="font-family: "Palatino Linotype", serif;">
– a planned, and systematic intervention done by testing laboratories that aims
to ensure that their services and processes will satisfy given requirements for
quality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">14.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Quality
Assessment</span></b><span style="font-family: "Palatino Linotype", serif;">
– processes undertaken by NRL – SLH/SACCL to monitor, evaluate, and document
the effectiveness of the QA program of testing laboratories (e.g., EQAS, site
visit).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">15.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Reactive
result</span></b><span style="font-family: "Palatino Linotype", serif;">
– when an HIV Testing or screening procedure indicates presence of HIV
antibodies and/or antigens. This result should be confirmed using the current
diagnostic algorithm.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">16.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">rHIVDa
(rapid HIV diagnostic algorithm)</span></b><span style="font-family: "Palatino Linotype", serif;"> – uses a combination of 2 or 3 rapid
test formats done in parallel or sequence on a sample that had a reactive
result in the initial test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">17.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Primary
HIV Care Clinic</span></b><span style="font-family: "Palatino Linotype", serif;">
– a private or public health facility that provides out–patient primary care
services to PLHIV including but not limited to HTS, clinical management,
patient monitoring, and other care and support services. ARV treatment can also
be accessed through these facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">18.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Social
Hygiene Clinics</span></b><span style="font-family: "Palatino Linotype", serif;">
– these are clinics of the local government unit (LGU) that specialized in the
management of Sexually Transmitted Infections.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo4; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l30 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Consent
for HIV Test:</span></b><span style="font-family: "Palatino Linotype", serif;">
All people receiving HTS shall give written informed consent to be tested and
counselled. They shall be informed of the process for HIV test and counselling
and their right to decline.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l30 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Confidentiality:</span></b><span style="font-family: "Palatino Linotype", serif;"> HTS shall be
confidential, and client’s privacy shall be always ensured. The counselling
session between the HTS provider and the client, including test results shall
not be disclosed to anyone else without the written consent of the person being
tested except as stipulated in R.A. 8504.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l30 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Counselling:</span></b><span style="font-family: "Palatino Linotype", serif;"> All HIV testing
shall be accompanied by appropriate and high–quality counselling. Public and
private facilities performing HIV test shall provide pre– and post–HIV test
counselling to all clients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l30 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Correct
Results:</span></b><span style="font-family: "Palatino Linotype", serif;">
There shall be accurate tests and prevention of false positive results through
continued adherence to quality standards and procedures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l30 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Connection
to Care:</span></b><span style="font-family: "Palatino Linotype", serif;">
All clients shall be linked to prevention, treatment, and care services. These
services shall include effective and appropriate follow–up, including long–term
prevention and treatment support. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Informed
Consent</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Client’s consent must be obtained prior
to HIV test in the following forms:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Verbal
consent, form clients 18 years and above, is adequate only in community–based
HIV screening services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Written
informed consent form the client shall be secured first before proceeding to
HIV testing for clients of legal age (see Annex I – A).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
the following conditions, written consent can be provided by persons aside from
the client as provided by Philippine Laws (R.A. 8344, R.A. 10354):</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
infants/children born to HIV positive mothers, persons below 18 years old
needing HIV test, and patients who are comatose or mentally incapacitated,
consent for HIV test shall be provided by the nearest of kin.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l14 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
addressing serious cases, as defined in R.A. 8344, that deem HIV test to be a
crucial diagnostic test to proceed with clinical management, consent for HIV
Test can be provided by a Licensed Social Worker for minors, mentally
incapacitated, and comatose patient only if consent from parents or nearest of
kin cannot be obtained, in accordance with the provisions of R.A. 10354,
section 23.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Screening</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">HIV
screening procedure shall only be regarded as an additional HIV risk screening
tool and shall not be considered as first test in the diagnostic algorithm.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Healthcare
workers (Doctors, Nurses, Medical Technologists, Midwives) are allowed to perform
the procedure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Community–based
HIV screening, with linkage to prevention, treatment, and care, shall be
offered to key populations. Trained and supervised lay providers can
independently conduct sage and effective HIV screening using rapid diagnostic
kits.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Pre–HIV
Test Counselling</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Confidentiality
of all data to be gathered form the client shall be emphasized.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV Counsellor shall provide the following information to the client:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l17 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
provider–initiated testing, HIV, and its relationship with client’s current
health condition (i.e., STI, Tuberculosis, Hepatitis B and C, and pregnancy)
and the benefit of knowing one’s HIV status.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l17 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Flow
of the HIV test procedures in the clinic.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
client shall be given chance to express any other concern or needs in relation
to HIV and test procedures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV Counsellor shall review/validate the information provided in the DOH EB
Form A / A – MC (see Annex II).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
necessary, the HIV Counsellor shall assist the client in the completion of
information in the DOH EB Form A / A – MC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
client shall be asked to sign the consent for HIV Test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Counsellor shall log the information needed in the HTS daily registry, and
individual client record (See Annex III and IV respectively).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Counsellor shall accompany the client to the laboratory for testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Conduct
of HIV Testing</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">All HTS facilities shall adhere to the
operational requirements as stated in Annex V and HIV testing standard criteria
for laboratories set by NRL – SLH/SACCL (see Annex VI).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">HIV
testing shall be routinely offered, prioritized and promoted to the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Key
populations including adolescents. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">High
risk individuals who have not been tested recently. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Partners,
infants, and children of PLHIV. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Patient
showing signs and symptoms consistent with AIDS defining illness. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Patient
with Sexually Transmitted Infections. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Patient
with Hepatitis B and C. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Patient
with under nutrition not responsive to interventions. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
confirmed tuberculosis patients. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
pregnant women regardless of risk.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">HIV
testing shall be provided to any client who go to the HTS facility with
expressed intention or need to undergo the test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Only
a Registered Medical Technologists with HIV
proficiency training certificate shall perform the HIV test procedure using DOH
Food and Drug Administration (FDA)–registered test kits. Reactive blood samples
from the populations shall be sent to NRL – SLH/SACCL or its designated and
certified confirmatory rapid HIV diagnostic algorithm (rHIVda) facility sites.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; text-indent: 18.0pt;"><b><u><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Testing Procedures</span></span></u></b></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV Counselor shall endorse the client for testing to a licensed and HIV
proficient Medical Technologist and shall submit the DOH – EB Form A / A – MC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV proficient medical technologist shall ensure that EB Form A / A – MC was
properly filled out and signed by the client before performing blood
extraction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV proficient medical technologist shall ensure that HIV testing is performed
according to the work instruction or standard procedures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Alternatively,
a nurse phlebotomist may extract blood from the client and shall endorse the
specimen to the HIV proficient medical technologist for testing. Nurse phlebotomists
are required to undergo training in specimen handling to prevent mislabelling,
losing specimens and other pre–analytical errors.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
the result is nonreactive, the medical technologist and supervising Pathologist
or Physician shall provide validated official laboratory result to the HIV Counsellor
or requesting Physician for post–HIV test counselling.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
the result is reactive, the medical technologist shall repeat the test on the
same blood sample, then send the specimen to NRL – SLH/SACCL or its designated
confirmatory rHIVda laboratory for confirmatory testing (see Annex VII
Confirmatory Request Form). The reactive specimen must be refrigerated and sent
within one week of extraction. However, if the reactive test is done in a
confirmatory rHIVda site, then the medical technologist shall proceed to
performing the confirmatory rHIVda.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
medical technologist shall maintain a log of all necessary client information
including the HIV test result before releasing the result to the HIV Counselor
or requesting Physician for post–HIV test counselling.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Post–HIV
Test Counselling</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Post–HIV
Test Counselling: Non–Reactive Result</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l33 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV Counsellor shall do the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l20 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
the client an official copy of the HIV non–reactive test result signed by an
HIV–proficient medical technologist who performed the test and validated by a
Pathologist. For Special Hygiene Clinics and TB DOT facilities without a
Pathologist, the supervising Physician shall review, validate, and countersign.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l20 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Explain
that the client may either be non-infected or may have been infected from the
most recent exposure, but his/her body has not produced sufficient level of
antibodies that can be detected by the HIV test kit.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l20 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Check
for the latest or ongoing significant risk. If the client reports of a major
significant risk, the Counsellor shall:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126.0pt; mso-list: l27 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(a)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Emphasize
the importance of knowing the HIV status of sexual partner(s). Counsellor shall
recommend for the sexual partner(s) to undergo HIV testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126.0pt; mso-list: l27 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(b)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate
risk reduction planning, discuss prevention of HIV infection, and the
importance of maintaining an HIV negative status.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126.0pt; mso-list: l27 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(c)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Offer
retesting after 6 weeks from the last HIV test result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126.0pt; mso-list: l27 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(d)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Refer
the client for continuous support, STI & HIV prevention services and other
appropriate services from partner community–based organizations. Provide a
referral letter (see Annex I – B).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l33 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">After
post–HIV test counselling, clients shall be requested to complete the Client
Satisfaction Form (HTS Client Satisfaction Survey Form – Annex I – D).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Post–HIV
Test Counselling: Reactive Result</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">No written reactive HIV test results
shall be released to clients. Reactive blood samples shall be sent for
confirmatory testing to NRL – SLH/SACCL or its designated Confirmatory rHIVda
site.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Clients
shall be verbally informed of the HIV reactive test results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Clients
shall be appropriately linked to care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV Counsellor shall perform the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l2 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Explain
to the client that a reactive result means possible HIV infection and the blood
sample will be submitted for confirmatory testing. Provide ample time to allow
him/her to absorb the information and/or to ask questions for clarification or
further information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l2 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate
risk reduction planning and discuss prevention of multiple HIV infection and
other STI including Hepatitis B and C. Condoms and lubricants are provided
along with information of their correct use.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l2 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Emphasize
the importance of knowing the HIV status of sexual partner(s). counsellors
shall recommend for the sexual partner(s) to undergo HIV testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l2 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Advise
the client/facilitate screening for TB, Hepatitis B and C, Syphilis and other
STI.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l2 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(5)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Emphasize
the importance of early assessment by a treatment hub Physician and provide a
referral letter for the client to be linked to a treatment hub or primary HIV
care facility chosen by the client.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l2 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(6)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
with a treatment hub or primary HIV care clinic and ensure that the client will
be seen by the Physician for further assessment and clinical management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
receiving treatment hub or primary HIV care clinic provides feedback to the
referring HTS facility once the client has reached its facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Post–HIV
Test Counselling: Positive Confirmatory Result</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">All official confirmatory test results
shall ONLY be released to the referring facility by the NRL – SLH/SACCL or by
its designated certified Confirmatory rHIVda testing sites. This is to ensure
that the release of HIV confirmatory test is accompanied by a post–test
counselling. Everyone who is diagnosed HIV–positive should receive post–test
counselling, including couples where one or both are diagnosed HIV–positive
after the PLHIV has disclosed his/her status to the intimate partner.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The NRL – SLH/SACCL and confirmatory
rHIVda testing facilities are required to report HIV positive results to the
Epidemiology Bureau of the Department of Health.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">It
is an ethical obligation of the HIV Counsellor to check the test result if it
is consistent with the label on the envelope and with that of the identified
client. Upon verification of the result, the HIV Counsellor, as previously
consented during pre–test counselling, shall contact the client for post–HIV
test counselling and release of confirmatory test result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">During
post–HIV test counselling, the HIV Counsellor shall release the official copy
of the confirmatory test result informing the client of the result simply,
clearly, and in an objective manner, and provide ample time to allow him/her to
absorb the information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV Counsellor shall do the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Help
the client cope with emotions arising from the test result.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Address
significant concerns and assist the client to identify who in her/his network
may be available and acceptable to offer immediate support.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Reinforce
risk reduction planning and other procedures found in sections 2.c.(2) to (4)
of Post–HIV Test Counselling: Reactive Result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Discuss
importance of disclosure of her/his HIV status to partner(s), family member(s)
and/or significant other(s). Help the client in a decision–making process to
facilitate disclosure by presenting different strategies to do so.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(5)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Encourage
and offer referral for counselling and testing of partners and children.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(6)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assess
the risk of violence or suicide and discuss possible steps to ensure the
physical safety of the client.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(7)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Inform
the client of the importance of / or offer early treatment in maintaining
health and transmission prevention and management of possible opportunistic
infections.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l9 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(8)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
the client a referral letter (see Annex I – B) and ensure that the client shall
be linked to the treatment hub or primary HIV care clinic of his/her choice for
access of retroviral therapy, management of possible opportunistic infections, care,
and support services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Post–HIV
Test Counselling: Negative Confirmatory Result</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">It
is an ethical obligation of the HIV Counsellor to check the test result if it
is consistent with the label on the envelope and with that of the identified
client. Upon verification of the result, the HIV Counsellor, as previously
consented during pre–test counselling, shall contact the client for post–HIV
test counselling and release of confirmatory test result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV Counsellor shall release the official copy of the confirmatory test result
informing the client of the result simply, clearly, and in an objective manner.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Follow
section E.1 under Post–HIV Test Counselling: Non–reactive Result (see page 5)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
sending laboratory shall perform the recommendations of the national reference
laboratory as indicated in the confirmatory result, if there is any.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Indeterminate
results or Inconclusive results</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In cases that NRL – SLH/SACCL will
release such test result to the sending laboratory, the latte shall perform the
recommendations of the national reference laboratory as indicated in the
confirmatory result. NO RESULT shall be released to the client at this point.
The laboratory should get a fresh plasma sample form the client and send to NRL
– SLH/SACCL for further tests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Connection
to Care</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clients
with reactive result</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
treatment hub or primary HIV care clinic who receives referred clients with initial
reactive result shall repeat HIV screening for the purpose of validating
client’s initial HIV test result. Specimen should not be sent to NRL –
SLH/SACCL for confirmatory testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
treatment hub or primary HIV care clinic Physician shall assess and manage the
clients according to the Enhancing Linkage to Care of PLHIV (D.C. No. 2016 – 0171).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clients
with confirmed positive HIV test result</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l8 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
clients diagnosed with HIV shall be managed in accordance to the Treatment
Guidelines of the Department of Health.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l8 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
treatment hub or primary HIV care clinic who receives the clients with
confirmed positive result may repeat HIV screening if deemed necessary before
initiating ART.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l8 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
clients diagnosed with HIV shall be linked to prevention, treatment, and care
services, which include effective and appropriate follow up, including
continuous adherence counselling once enrolled to lifelong treatment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Retesting</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Frequency of retesting shall be
recommended to the following:</span></span></p>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; margin-left: 54.0pt; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Population<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Frequency<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Key
Populations<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
3 months <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Pregnant
women who belong to key populations or a partner of PLHIV<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1<sup>st</sup>
trimester, 2<sup>nd</sup> trimester, 3<sup>rd</sup> trimester, and at least
once while breastfeeding<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Casual
or intimate partners of key populations of PLHIV<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 225.4pt;" valign="top" width="301">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Annual
<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Monitoring
and Evaluation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">All HTS facility shall maintain daily
client registry and monthly monitoring report (See Annex II and VII for the
Reporting Forms). These should be submitted to LGU NASPCP coordinator. The
programmatic evaluation of HTS will be covered by the annual Monitoring and
Evaluation Plan for the Philippine Health Sector’s Strategic Plan for HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">All HIV testing laboratories shall be
subjected to regular quality assessment and evaluation in compliance to quality
management system implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Roles
and Responsibilities</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Disease
Prevention and Control Bureau shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l24 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Formulate
plans and policies in the improvement of HTS strategy. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l24 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Review
the HTS training programs relative to the implementation of this policy. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l24 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop
Operations Guidelines on Community–based HIV Screening.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Epidemiology
Bureau (EB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l19 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain
and update HIV/AID and ART Registry of the Philippines. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l19 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Collect
required data from sites and provide the status of outcomes of HTS. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l19 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
quarterly updates on the surveillance of HIV/AID to National HIV, AIDS and STI
Prevention and Control Program (NASPCP).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
– Regional Offices (DOH – RO) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l31 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Advocate
the setting up of HTS facilities in local government units. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l31 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
monitoring and evaluation activities on HTS. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l31 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Manage
HTS related commodities. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l31 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate
capability building activities regarding HTS. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l31 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Strengthen
the service delivery network for HTS and regularly update its directory. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l31 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
testing site’s compliance to certification, licensing, and accreditation
(laboratories, clinical facilities)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l31 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitor
and supervise implementation of HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">NRL
– SLH/SACCl shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l1 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop
accreditation criteria on HIV confirmatory testing for other agencies. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l1 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Set–up
national referral centers for HIV confirmatory tests. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l1 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
regular review of the national testing algorithm.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l1 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Mentor
HIV testing facilities on the development of site standard operating procedures
(SOP) and job aids. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l1 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Train
Clinic Physicians on monitoring HIV laboratory procedures while Pathologists
are still being hired.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">rHIVda
sits shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Implement
the rHIVda and HTS guidelines accordingly. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Comply
with the requirements set by NRL – SACCL as stated in the guidelines on the
implementation of the rHIVda. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop
and maintain effective documented SOPs. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Palatino Linotype, serif;">d.</span> <span style="font-family: "Palatino Linotype", serif;">Maintain
close collaboration with NASPCP, EB, Treatment Hubs, Primary HIV care
facilities, LGU and NRL – SLH/SACCL to promote an overall efficient management
system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
treatment hubs and DOH hospitals shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Integrate
HTS in all relevant departments through the coordinative function of HIV and
AIDS Core Teams. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
necessary data to EB for the monitoring of HIV cascade indicators, HTS, etc.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Local
Government Unit shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Institutionalize
the implementation of the guidelines through a local resolution by the local
health board or as may be appropriate. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Implement/conduct
HTS in various departments of hospitals, Social Hygiene Clinic, and primary HIV
care clinics and other HIV testing facilities. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that HIV policies are implemented in every workplace, both private and public,
within their area of responsibility. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that infrastructures of the facilities implementing HTS are fully functional. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Promote
adherence to SOPs at all levels of service providers. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Support
implementation of quality control and participate in External Quality Assurance
Scheme. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
sufficient test kits and supplies for HTS implementation. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l35 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitor
and evaluate HTS implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Non–Government/Community–based/Civil
Society Organizations are encouraged to:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l29 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
in the dissemination of this policy through training education and advocacy. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l29 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
linkage to HTS facility and facilitate client referral and feedback.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l29 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
feedback to NASPCP on the quality of HTS. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l29 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
and collaborate on community – based HIV screening implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l26 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">WHO/UNICEF
and other bilateral partners are encouraged to:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo37; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
technical support in ensuring coordinated strategies in HTS implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l28 level1 lfo37; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
in monitoring and evaluation and provide recommendation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Funding</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Disease Prevention and Control
Bureau – National HIV, AIDS and STI Prevention and Control Program shall
allocate budget for the implementation of these policies and guidelines
including procurement of HIV test kits and funds for monitoring and supervision
activities. Other DOH offices and DOH hospitals shall support financially, as
part of their annual budget, the implementation of these policies and
guidelines in their respective regions/institutions.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><a href="http://mt-lectures.blogspot.com/2017/08/administrative-order-no-2010-0028.html" target="_blank">Administrative Order 2010 – 0028</a> entitled “Policies and Guidelines in the
Conduct of Human Immunodeficiency Virus (HIV) Counselling and Testing in
Community and Health Facility Settings” </span><span style="color: #fcff01; font-size: large;">is hereby repealed</span><span style="color: #01ffff; font-size: large;">.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l34 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Administrative Order shall take
effect immediately.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">PAULYN
JEAN B. ROSELL – UBIAL, MD, MPH, CESO II<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary
of Health</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-55276520569213498052023-05-29T18:05:00.000+08:002023-05-29T18:05:47.020+08:00Administrative Order No. 2022 – 0010<p><span style="color: #01ffff; font-size: large;"> </span></p><p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">25 March 2022<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">GUIDELINES ON TUBERCULOSIS – HUMAN IMMUNODEFICIENCY
VIRUS (TB – HIV) SERVICES INTEGRATION FOR UNIVERSAL HEALTH CARE (UHC)
IMPLEMENTATION<o:p></o:p></span></span></b></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p> </o:p></span><b style="text-indent: -36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b style="text-indent: -36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">The collaborative approach of prevention and control of Tuberculosis
(TB) and Human Immunodeficiency Virus (HIV) of the Department of Health (DOH)
was catalyzed with the issuance of </span><span style="font-family: "Palatino Linotype", serif;">Administrative Order
No. 2008 – 0022</span><span style="font-family: "Palatino Linotype", serif;">, entitled “Policies and Guidelines in the Collaborative
Approach of TB and HIV Prevention and Control” and its further revision through
</span><span style="font-family: "Palatino Linotype", serif;">Administrative Order No. 2014 – 0005. </span><span style="font-family: "Palatino Linotype", serif;">With the
enactment of Republic Act No. 11223 or the Universal Health Care Act, TB and
HIV are identified as flagship programs for integration in the UHC
implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">The Philippine Health Sector HIV Strategic Plan 2020 – 2022 enumerates
high impact prevention, testing, treatment, and adherence strategies targeting
high risk key populations in high burden areas. Innovative and differentiated
approaches for HIV treatment and adherence involve introducing safer treatment
regimen, managing co–infections such as TB, enhancing case management, and
scaling up viral load testing.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Similarly, the updated Philippine Strategic TB Elimination Plan 2020 –
2023 (PhilSTEP1) enumerates the strategies for screening, testing and
diagnosis, treatment, and prevention that will contribute to the Global End TB
objectives. Part of these strategies are integrated patient–centered care including
TB – HIV collaboration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This policy consolidates the key components of the above strategies and
guidelines pertaining to TB and HIV with the goal of reducing the burden of TB
among people living with HIV (PLHIV) and the burden of HIV among people with TB
towards the attainment of goals of the UHC Act and FOURmula One Plus for Health
(F1 Plus).</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">OBJECTIVE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Order is issued to provide standards and mechanisms for
collaboration between the National TB Control Program (NTP) and National AIDS
and STI Prevention and Control program (NASPCP) for the provision of TB and HIV
services under UHC.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SCOPE OF APPLICATION</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">These guidelines shall apply to all public and private health facilities
providing TB and HIV services from screening, diagnosis, treatment, and
prevention. In the case of the Bangsamoro Autonomous Region in Muslim Mindanao
(BARMM), the adoption of these guidelines shall be in accordance with R.A. No.
11054 (Bangsamoro Organic Law) and the subsequent laws and issuances to be
issued by the Bangsamoro government.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">DEFINITION OF TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Active drug safety monitoring and management (aDSM)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to the reporting of all serious adverse
events (SAE) and adverse events of special interests (AESI) among patients
using new drugs and new treatment regimen.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Antiretroviral therapy (ART)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to lifelong treatment using a combination of three or more
anti – retroviral (ARV) drugs to achieve viral suppression.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Nucleic acid amplification test (NAAT)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – (e.g., GeneXpert test) refers to a semi–automated, molecular assay
which permits rapid diagnosis through the detection of nucleic acid (DNA/RNA).
It is used to detect TB, COVID, and other infectious diseases as well as
determine the viral load among PLHIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Community–based treatment</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers
to taking the TB medications in a designated location in the community, usually
near the patient’s residence, with a health worker or community volunteer
acting as treatment supporter.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Digital adherence technologies</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refer to tools designed to support people with TB that allow them to
take their medications at a place and time that is convenient to them, while
remaining connected to their health care provider.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Health facilities</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refer to an
institution that has healthcare as its core service, function, or business.
Health care pertains to the maintenance or improvement of the health of
individuals or populations through the prevention, diagnosis, treatment,
rehabilitation and chronic management of disease, illness, injury and other
physical and mental ailments or impairments of human beings.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV testing</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to any
procedure used to identify the presence or absence of HIV in a person’s body
which includes a test for triage or HIV screening, laboratory – based or
facility–based testing, mobile procedures, and other approaches.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV testing services</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refer to a
broad range of services that shall be provided alongside HIV testing. These
services include counselling, linkage to necessary and appropriate HIV
prevention, treatment and care, and other clinical support services, as well as
coordination with stakeholders to support quality assurance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Home–based treatment</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to
taking the TB medications at home assisted by a family treatment supporter or
using digital adherence technologies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Key populations</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refer to
populations with high risk of contracting HIV but not limited to males who have
sex with males, transgender women, people with multiple sex partners, and
people who inject drugs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">K.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Patient–centered care</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to an
approach to care that recognizes and respects the patient’s rights and values
and considers the patient as an important partner who actively participates in
decisions on diagnosis and treatment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">L.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Differentiated service delivery</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to a person – centered approach that simplifies and adapts HIV
services across the cascade to reflect the preferences and expectations of various
groups of PLHIV while reducing unnecessary burdens on the health system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">M.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">TB preventive treatment (TPT)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to treatment offered to individuals who are
at risk of developing active TB disease to reduce that risk.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">N.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">TB screening</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refers to the
systematic identification of presumptive TB in a predetermined target group,
using examinations or other procedures that can be applied rapidly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">O.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Young key populations</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – refer to
populations within the age range of 15 – 24 years old with high risks or
contracting HIV but not limited to males who have sex with males, people with
multiple sexual partners, and people who inject drugs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">GENERAL GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Health facilities shall provide integrated TB and HIV services to all
patients and ensure appropriate referral of cases within the health care
provider network (HCPN).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The DOH and local government units (LGUs) shall ensure that adequate
commodities for the provision of TB – HIV services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Resources from the national and local governments, private sector, and
partners shall be pooled and harmonized through the Special Health Fund to
ensure efficient budgeting and to minimize catastrophic costs to patients and
to avoid overlapping of provision of services and proper role delineation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Health care workers shall be capacitated to provide both TB and HIV
services according to standards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Appropriate and timely TB and HIV treatment shall be given to all newly
diagnosed TB or HIV patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">A Data Sharing Agreement shall be issued to ensure that data captured on
information systems related to TB and HIV will be rationally shared to better
manage both programs while maintaining confidentiality and security of data as
required by R.A. No. 10173 or the Data Privacy Act of 2012.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Infection prevention and control measures shall be strictly observed in
the delivery of TB and HIV services.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo3; text-indent: -18pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SPECIFIC GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l25 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Prevention</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All PLHIV who do not have active TB shall receive TB preventive
treatment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All household and close contacts of diagnosed TB cases in whom TB have
been ruled out shall be assessed for eligibility to TPT. TPT shall be offered
for those found eligible. Please refer to the NTP Manual of Procedures (MOP), 6<sup>th</sup>
Ed. (2020), page 70, Table 29 for TPT regimens, which can be accessed through </span><span style="font-family: "Palatino Linotype",serif;"><a href="https://tinyurl.com/NTPMOP-6th"><span lang="EN-US">https://tinyurl.com/NTPMOP-6th</span></a></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Education, counselling, and social communication on TB and HIV
prevention shall be provided as part of the comprehensive care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV prevention commodities such as condoms and lubricants shall be
appropriately provided to TB and HIV patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Existing service delivery networks shall be maximized for advocacy,
demand generation, service delivery, and implementation of other TB – HIV
related activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l25 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Detection</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Early identification of TB among PLHIV shall be done through careful
assessment of signs and symptoms (fever, weight loss, cough, night sweats) at
every visit and by doing chest X–ray upon diagnosis of HIV and at least
annually. GeneXpert shall be done anytime a patient has TB signs and symptoms
or chest X–ray findings suggestive of TB. Please refer to the NTP MOP, page 12,
Figure 2, which can be access through </span><span style="font-family: "Palatino Linotype",serif;"><a href="https://tinyurl.com/NTPMOP-6th"><span lang="EN-US">https://tinyurl.com/NTPMOP-6th</span></a></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All patients consulting the health facility shall also be screened for
TB according to algorithms in the NTP MOP, page 12, Figure 1, which can be
accessed through </span><span style="font-family: "Palatino Linotype",serif;"><a href="https://tinyurl.com/NTPMOP-6th"><span lang="EN-US">https://tinyurl.com/NTPMOP-6th</span></a></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All TB patients aged at least 15 years old shall be offered HIV testing
services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NAAT/GeneXpert shall be used as primary diagnostic tool for
diagnosis of TB among presumptive TB and for point–of–care HIV viral load
testing for PLHIV on Antiretroviral Therapy (ART).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">A laboratory network analysis for TB and HIV shall be implemented to
determine the optimal number and location of required NAAT machines based on
testing targets and population served.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The LGUs shall coordinate with the Centers for Health Development (CHDs)
to ensure that the recommended laboratory sites for both TB and HIV are within
the regional laboratory network and referral system among laboratories in the
HCPN in their respective regions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Existing specimen transport systems shall be optimized for both TB
(sputum) and HIV viral load testing (blood) and shall also be utilized for
transport of the results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All public and private providers are mandated to report to the DOH all
diagnosed TB and HIV patients using available platforms (e.g., Integrated TB Information
System or ITIS, and One HIV, AIDS, and STI Information System or OHASIS) as
part of the strengthening disease surveillance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l25 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Infection Prevention and Control</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Minimum public health standards shall be implemented in all health
facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All health facilities providing TB and HIV services shall implement
administrative controls, engineering controls and use of personal protective
equipment based on a facility risk assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l25 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Treatment</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Standard regimens for drug–susceptible and drug–resistant TB shall be
used based on eligibility criteria. Please refer to the NTP MOP, page 35,
Figure 6 and page 45, Table 18, which can be accessed through </span><span style="font-family: "Palatino Linotype",serif;"><a href="https://tinyurl.com/NTPMOP-6th"><span lang="EN-US">https://tinyurl.com/NTPMOP-6th</span></a></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Antiretroviral therapy (ART) shall be initiated within the same day upon
recognition of HIV infection, whenever possible, regardless of clinical and
immunologic status.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Persons with TB – HIV co–infection shall be given both TB and HIV
treatment based on DOH guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Patients with TB – HIV co–infection shall also be managed for prevention
of other opportunistic infections (OIs). For the list of OIs, please refer to
the DOH Department Memorandum (DM) No. 2020 – 0338, entitled “Adoption of PSMID
Clinical Practice Guidelines on the Prevention, Diagnosis and Treatment of
Opportunistic Infections in HIV Infected Adults and Adolescents in the
Philippines,” which be accessed through </span><span style="font-family: "Palatino Linotype",serif;"><a href="https://tinyurl.com/OI-Guidelines"><span lang="EN-US">https://tinyurl.com/OI-Guidelines</span></a></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Treatment adherence support and counselling shall be given to all
patients with TB, HIV and TB – HIV co–infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Patient–centered care and differentiated service delivery through home–based
and community–based treatment shall be practiced.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">When available, digital adherence technologies shall be used.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Active drug safety monitoring and management (aDSM) shall be implemented
for novel drugs and treatment regimens by reporting severe adverse events (SAE)
and adverse events of special interest (AESI).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l25 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provision of Commodities</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The DOH and LGU shall ensure adequate commodities for the provision of
TB – HIV services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l6 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The following commodities shall be procured by the DOH – Disease
Prevention and Control Bureau and transitioned to the LGUs based on the DOH–approved
Devolution Transition Plan as aligned with the UHC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Cartridges for Xpert TB test <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV point of care Viral Load (VL) cartridges <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV testing kits<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">CD4 cartridges <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">First–line anti–TB drugs for susceptible TB for adults, and children.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Selected second line anti–TB drugs for drug resistant TB (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3678673/" target="_blank">Bedaquiline</a> and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4156838/" target="_blank">Delamanid</a>). Other second line anti–TB
drugs will be provided by the Global Fund. As part of the sustainability
measure, the government will continuously increase its commitment to provide
these commodities annually. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Drugs for antiretroviral therapy (ART) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Drugs for TB preventive treatment <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l14 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Isoniazid for 6 months (6H) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l14 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Isoniazid + Rifampicin combination for 3 months (3HR) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l14 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Isoniazid + Rifapentine combination for 12 weekly doses (3HP) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l14 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Rifampicin for 4 months (4R) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Trimethoprim – Sulfamethoxazole (Cotrimoxazole) for prophylaxis or
treatment of Pneumocystis pneumonia. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Azithromycin for Mycobacterium avium complex prophylaxis (Note: for
devolution in 2023) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Condoms and lubricants<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">l.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Personal protective equipment (PPE)</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l6 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">LGUs shall be responsible for providing or procuring the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Chest X–ray for TB screening (provisions or referral) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Specimen containers (sputum cups and blood collection vials)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Glass slides <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Staining kits for direct sputum smear microscopy <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Purified protein derivative (for Tuberculin skin test) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Cartridges for Xpert TB test (augmentation) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV testing kits (augmentation) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV point of care VL cartridges (augmentation) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">CD4 cartridges (augmentation) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Azithromycin for Mycobacterium avium complex (prophylaxis (Note: for
devolution in 2023)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Condoms and lubricants (augmentation) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l23 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">l.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">PPE (augmentation)</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l6 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Health facilities through PhilHealth Outpatient HIV/AID Treatment (OHAT)
package:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Consumables for HIV VL testing (EDTA tubes, cryovials) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Point of care HIV VL cartridges<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">CD4 cartridges</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l25 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Capacity Building</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l17 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Health workers in hospitals, health centers/rural health units, TB
facilities, and HIV treatment facilities including barangay health workers and
community volunteers shall be trained in TB and HIV care, particularly on the
following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">NTP Manual of Procedures, 6<sup>th</sup> Ed.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">HIV counselling, testing, and treatment<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Use of GeneXpert for TB diagnosis and HIV viral load testing<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Integrated TB Information System (ITIS) and One HIV, AIDS, and STI
Information System (OHASIS)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Procurement and supply management</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">MONITORING AND EVALUATION</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l29 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Standard indicators shall be used to monitor TB and HIV program
performance:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">No. of TB patients with known HIV status (tested for HIV) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">No. of PLHIV screened for TB <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">No. of patients with TB – HIV co–infection <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">No. of PLHIV given TB preventive treatment<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Treatment outcome of patients placed on TB treatment and TB preventive
treatment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l29 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Other TB and HIV indicators not directly related to TB – HIV integration
shall continue to be monitored.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l29 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Data for the standard indicators shall be reported by all health
facilities following regular program reporting through ITIS and OHASIS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l29 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Data sharing between ITIS and OHASIS shall be implemented for
harmonization of TB – HIV indicators.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l29 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Integrated monitoring and program implementation reviews shall be done
for both TB and HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l29 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The TB – HIV Integration Technical working group shall convene to monitor
program implementation and perform other functions as stated in DOH A.O. No.
2014 – 0005. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">ROLES AND RESPONSIBILITIES</span></b><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Disease Prevention and Control Bureau (DPCB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop the plan for implementation of the TB – HIV integration. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure adequate commodities for TB and HIV. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop capacity–building tool for TB – HIV integration. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide technical assistance to CHDs in implementation of the TB – HIV
integration guidelines. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Monitor and evaluate implementation of TB – HIV service integration and
provide regular feedback to the Public Health Services Team (PHST).<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop additional policies and guidelines, as necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Epidemiology Bureau (EB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l5 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Maintain and update surveillance systems that capture TB – HIV data and
monitor TB – HIV indicators.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l5 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Collect and validate required data from facilities providing HIV
services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l5 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide monthly updates on TB – HIV–related strategic information to the
DPCB, partners, and other stakeholders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l5 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop and maintain the OHASIS and ensure availability to its end
users.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l5 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Maintain the electronic recording and reporting system of HIV including
providers and facilities databases.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Health Promotion Bureau (HPB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l10 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure the promotion of integrated TB – HIV as part of the DOH Campaign
for Primary Care such as KosulTayo, and in coordination with the Presidential
Communications Operations Office (PCOD) for information dissemination.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l10 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop Social Behavior Change Communication (SBCC) plan and its
corresponding materials in different platforms.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l10 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Monitor the implementation of the SBCC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l10 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Evaluate the impact of the integrated TB – HIV SBCC to target
individuals/populations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Knowledge Management and Information Technology Service (KMITS)
shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l22 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop and maintain the Integrated TB Information System (ITIS) and
ensure availability to its end users.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l22 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Maintain the electronic recording and reporting system of TB including
providers and facilities databases.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l22 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure data privacy of patient’s personal information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Centers for Health Development (CHDs) and Ministry of Health –
Bangsamoro Autonomous Region in Muslim Mindanao (MOH – BARMM) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Lead capacity building of LGU health facilities in TB – HIV integration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Coordinate with LGUs in the distribution and procurement of necessary
commodities for implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Collaborate with LGUs to develop the referral system for the TB and HIV
laboratory network including, but not limited to the referral procedure for HIV
VL testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide technical assistance to LGUs and facilities, both public and
private, in the implementation of the guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Monitor and evaluate implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide feedback and quarterly program reports to DPCB to guide policy
revision or development.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Local Government Units (Provincial, City, and Municipal Levels)
shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Co–lead in capacity–building activities related to TB and HIV and
procurement and supply management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Implement the guidelines on TB and HIV integration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Implement awareness and demand generation activities at the local level.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Establish the referral system including, but not limited to a laboratory
network.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure adequate supply of commodities for TB – HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide feedback and quarterly program reports to CHDs and participate
in monitoring and review activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide and ensure access to transport mechanisms for patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Health Facilities shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l26 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide TB and HIV services in accordance with DOH guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l26 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensure mechanisms and standards are in place for provision of TB and HIV
services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Reference Laboratories</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l4 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Research Institute for Tropical Medicine – National Tuberculosis
Reference Laboratory (RITM – NTRL) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide technical guidance on CBNAAT machine (e.g.,
GeneXpert) placement, installation, capacity
building and operations.</span></span></p>
<div style="text-align: center;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/yjTNB7g41so" title="YouTube video player" width="560"></iframe></div><p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Monitor and provide recommendations on operations of GeneXpert
laboratory.</span></span></p>
<div style="text-align: center;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/ExHj-pc30Dc" title="YouTube video player" width="560"></iframe></div><p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct EQA in the use of CBNAAT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct Training of Trainers for the use of CBNAAT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l4 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The National Reference Laboratory – San Lazaro Hospital STD AIDS
Cooperative Central Laboratory (NRL – SLH/SACCL) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l11 level1 lfo28; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide External Quality Assessment Schemes (EQAS) for Serology to HIV
testing facilities and GeneXpert sites performing HIV Viral Load testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l11 level1 lfo28; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct of Training of Trainers of the Regional HIV – TB Coordinators on
Laboratory Quality Management System, Referral Networking and Monitoring and
Evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l11 level1 lfo28; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct Kit Evaluation for the registration of test kits to be used in
the HIV testing facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l11 level1 lfo28; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Resolve laboratory discrepancies and concerns regarding HIV testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Non–government/Community–based/ Civil Society Organizations shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l19 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Advocate for political support and resource mobilization for TB – HIV
program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l19 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide support to patients in detection and treatment for both TB and
HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l19 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide support to LGUs in terms of TB and HIV awareness.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l19 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Actively engage in community–led monitoring of TB – HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l19 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Coordinate with local authorities for appropriate delivery of TB and HIV
services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l19 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Engage in consultations for policy and guidelines development.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Development and other external partners shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l12 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide technical assistance in planning, implementing, capacity
building, monitoring, and evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l12 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide support for TB – HIV commodities and activities.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l12 level1 lfo30; text-indent: -18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">FUNDING</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The DPCB shall allocate funding through the Communicable Disease Budget
line item for implementation of these guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">X.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SEPARABILITY CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">If any clause, sentence, or provision of this Order shall be declared
invalid, unconstitutional, illegal, or unenforceable, the other provisions not
acted thereby shall remain, vital, valid, and effective.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">XI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The DOH <a href="https://mt-lectures.blogspot.com/2017/08/administrative-order-no-2008-0022.html" target="_blank">A.O. No. 2008 – 0022</a> entitled “Policies
and Guidelines in the Collaborative Approach of TB and HIV Prevention and
Control,” and <a href="http://mt-lectures.blogspot.com/2017/08/administrative-order-no-2014-0005.html" target="_blank">A.O. No. 2014 – 0005</a> entitled “Revised
Policies and Guidelines in the Collaborative Approach of TB and HIV Prevention
and Control” and other issuances, rules, and regulations inconsistent with or
contrary to this A.O. </span><span style="color: #fcff01; font-size: large;">are hereby repealed, amended, or modified accordingly</span><span style="color: #01ffff; font-size: large;">.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l13 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">XII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Administrative Order shall take effect after fifteen (15) days
following its publication in a newspaper of general circulation.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO T. DUQUE III, MD,
Msc<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary of Health </span><span style="font-size: 12pt;"><o:p></o:p></span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-88479493674983633842023-05-24T21:16:00.000+08:002023-05-24T21:16:01.255+08:00Expanded Newborn Screening Test <p><span style="color: #01ffff; font-size: large;"> </span></p><div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="4" style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 465.25pt;" valign="top" width="620">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype",serif;">EXPANDED
NEWBORN SCREENING PANEL</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">DISORDER GROUP<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">NAME OF THE DISORDER<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">ABB<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">METABOLITE
TESTED<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td rowspan="2" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Endocrine
Disorder<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/congenital-hypothyroidism/#causes" target="_blank">Congenital Hypothyroidism</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">CH<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Thyroid
Stimulating Hormone<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://my.clevelandclinic.org/health/diseases/17817-congenital-adrenal-hyperplasia" target="_blank">Congenital Adrenal Hyperplasia</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">CAH<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">17–hydroxy–progesterone
<o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">(17–a–OHP)
<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td rowspan="5" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Amino
Acid Disorder<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/homocystinuria/#causes" target="_blank">Homocystinuria</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">HCY<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Methionine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/hypermethioninemia/" target="_blank">Hypermethioninemia/Methionine Adenosyl Transferase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">MAT<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Methionine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/maple-syrup-urine-disease/" target="_blank">Maple Syrup Urine Disease</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">MSUD<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Leucine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/phenylketonuria/#description" target="_blank">Phenylketonuria</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">PKU<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Phenylalanine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.stlouischildrens.org/conditions-treatments/tyrosinemia" target="_blank">Tyrosinemia Type I, II</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><o:p> </o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Tyrosine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td rowspan="7" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Fatty
Acid Disorder<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/carnitine-palmitoyltransferase-i-deficiency/#description" target="_blank">Carnitine Palmitoyltransferase I Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">CPT
1<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Carnitine
Palmitoyltrasferase I<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/carnitine-palmitoyltransferase-ii-deficiency/#description" target="_blank">Carnitine Palmitoyltransferase II Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">CPT
2<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Hexadecanoylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/glutaric-acidemia-type-ii/#description" target="_blank">Glutaric Acidemia Type II</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">GA
II<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Butyrylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/long-chain-3-hydroxyacyl-coa-dehydrogenase-deficiency/#description" target="_blank">Long–Chain 3–Hydroxyacyl –CoA Dehydrogenase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">LCHAD<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Hydroxyhexadecanoylcarnitine
(AC16OH)<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.ncbi.nlm.nih.gov/books/NBK1424/" target="_blank">Medium Chain 3–Hydroxyacyl – CoA Dehydrogenase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">MCAD<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Octanoylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.newbornscreening.info/schadd-short-chain-3-hydroxyacyl-coa-dehydrogenase-deficiency/" target="_blank">Short Chain 3–Hydroxyacyl – CoA Dehydrogenase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">SCAD<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Butyrylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://rarediseases.org/rare-diseases/very-long-chain-acyl-coa-dehydrogenase-deficiency-lcad/" target="_blank">Very Long Chain 3–Hydroxyacyl – CoA Dehydrogenase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">VLCAD<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Tetradecanoylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td rowspan="6" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Organic
Acid<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/3-methylcrotonyl-coa-carboxylase-deficiency/#description" target="_blank">3–Methylcrotonyl CoA Carboxylase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">3MCC<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Hydroxyisovalerycarnitine
(AC5 – OH) <o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.nhs.uk/conditions/glutaric-aciduria/#:~:text=Glutaric%20aciduria%20type%201%20(GA1,and%20fish%20into%20amino%20acids." target="_blank">Glutaric Acidemia Type I</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">GA
I<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Glutarylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/isovaleric-acidemia/" target="_blank">Isovaleric Acidemia</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">IVA<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Isovalerycarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/ency/article/001162.htm#:~:text=Methylmalonic%20acidemia%20is%20a%20disorder,%22inborn%20error%20of%20metabolism.%22" target="_blank">Methylmalonic Acidemia</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">MMA<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Propionylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/holocarboxylase-synthetase-deficiency/#description" target="_blank">Multiple Carboxylase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">MCD<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Hydroxyisovalerylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/propionic-acidemia/#description" target="_blank">Propionic Acidemia</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">PA<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Propionylcarnitine<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Urea
Cycle Defect<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/citrullinemia/#description" target="_blank">Citrullinemia</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">CIT<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Citrulline<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Cystic
Fibrosis<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.nhs.uk/conditions/cystic-fibrosis/" target="_blank">Cystic Fibrosis</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">CF<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Immunoreactive
Trypsine (IRT)<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td rowspan="5" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Hemoglobino<o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">pathies<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.cedars-sinai.org/health-library/diseases-and-conditions---pediatrics/a/alpha-thalassemia-in-children.html" target="_blank">Alpha Thalassemia</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Hgb<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Hemoglobin<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="http://www.idph.state.il.us/HealthWellness/fs/beta_thalassemia_hcp.htm#:~:text=Infants%20with%20beta%20thalassemia%20develop,first%20two%20years%20of%20life." target="_blank">Beta Thalassemia</a><o:p></o:p></span></p>
</td>
<td rowspan="4" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><o:p> </o:p></span></p>
</td>
<td rowspan="4" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><o:p> </o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=160&ContentID=9" target="_blank">Hemoglobin C</a><o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.gov.uk/government/publications/baby-carries-a-gene-for-unusual-haemoglobin-description-in-brief/newborn-screening-your-baby-carries-a-gene-for-haemoglobin-d" target="_blank">Hemoglobin D</a><o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.stanfordchildrens.org/en/topic/default?id=hemoglobin-e-trait-160-12" target="_blank">Hemoglobin E</a><o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Biotinidase
Deficiency<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.ncbi.nlm.nih.gov/books/NBK1322/#:~:text=Clinical%20characteristics.,%2C%20skin%20rash%2C%20candidiasis)." target="_blank">Biotinidase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">BTND<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Biotinidase<o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td rowspan="2" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 89.45pt;" width="119">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Others<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://www.childrenshospital.org/conditions/galactosemia#:~:text=Initial%20signs%20usually%20present%20in,serious%20multiorgan%20involvement%20including%20death." target="_blank">Galactosemia</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">GAL<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">Total
Galactose <o:p></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31; mso-yfti-lastrow: yes;">
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 168.45pt;" width="225">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><a href="https://medlineplus.gov/genetics/condition/glucose-6-phosphate-dehydrogenase-deficiency/#description" target="_blank">Glucose–6–Phosphate Dehydrogenase Deficiency</a><o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 49.7pt;" width="66">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">G6PD
Def<o:p></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 157.65pt;" width="210">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">G6PD
enzyme activity<o:p></o:p></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;"><o:p> </o:p></span></p>
<p class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: large;">SAMPLE
COLLECTION FOR NEWBORN SCREENING TEST <o:p></o:p></span></p>
<div style="text-align: center;"><span style="color: #01ffff; font-size: large;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/vxshWngJ114" title="YouTube video player" width="560"></iframe></span></div>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-72471545068606177482023-05-24T20:03:00.001+08:002023-05-25T22:17:58.814+08:00Administrative Order No. 2020 – 0052<p><span style="color: #01ffff; font-size: large;"> </span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">27
October 2020 <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;"><span style="font-size: x-large;">REVISED
GUIDELINES ON THE IMPLEMENTATION OF THE EXPANDED NEWBORN SCREENING PROGRAM</span><span style="font-size: large;"><o:p></o:p></span></span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">BACKGROUND/RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><a href="https://mt-lectures.blogspot.com/2018/06/republic-act-no-9288.html" target="_blank">Republic Act 9288</a></span><span style="font-family: "Palatino Linotype", serif;">, otherwise
known as the “<a href="https://mt-lectures.blogspot.com/2018/07/irr-of-republic-act-no-9288.html" target="_blank">Newborn Screening Act of 2004</a>” provides for the establishment of
a national comprehensive newborn screening system that includes (i) education
of relevant stakeholders; (ii) screening, recalling and diagnosis of patients;
(iii) provision of medical/dietary/surgical management to address the untoward
consequences of heritable conditions when left untreated and (iv) evaluation
activities to assess long term outcome, patient compliance and quality
assurance of short term and long term follow up. The principles being carried
out by the Republic Act 9288 of universality, inclusivity, and
person–centeredness are the same principles that Department of Health (DOH)
ushers in through Republic Act 11223 or the
Universal Health Care (UHC) Act.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Expanded Newborn Screening (ENBS) as
an option to the NBS basic 6– test was implemented in November 2014 through the
issuance of DOH Administrative Order No. <a href="https://mt-lectures.blogspot.com/2018/06/administrative-order-no-2014-0045.html" target="_blank">2014 – 0045</a>.
Further, the National Policy and Strategic Framework on Expanded Newborn
Screening for 2017 – 2030, which was released on 05 November 2018 through the
issuance of DOH A.O. No. <a href="https://mt-lectures.blogspot.com/2023/05/administrative-order-no-2018-0025.html" target="_blank">2018 – 0025</a>, outlined
the shift to ENBS and the provision of continuing care for confirmed patients.
The ENBS Fee was later increased from Php 1,550 to Php 1,750 in March 2019 by
an amendment to A.O. No. 2014 – 0045 – A. The ENBS Fee augments other services
in addition to screening, such as confirmatory tests for the metabolic
conditions and hemoglobinopathies and life–saving management of newborns
diagnosed with metabolic disorders. PhilHealth worked on the full coverage of
the ENBS in the Newborn Care Package and released the Circular No. 2018 – 0021
on Enhancement of Newborn Care Package which includes the coverage of the ENBS
fee of Php 1,750.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">With the above–mentioned developments
and thrusts of the program towards full shift to ENBS, this Order shall serve
as reference for the full implementation of the ENBS to ensure the continuity
and sustainability of quality testing, follow-up services and management of
diagnosed newborn infants in the country with the provision of guidelines on
the transition of full expanded screening, on the establishment and operation
of Center for Human Genetic Services, and on the allocation of a portion of the
ENBS Fee to augment the cost of treatment and management of patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To update the guidelines on the
following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Implementation
of the Expanded Newborn Screening Program</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Expansion
of the National Comprehensive Newborn Screening System (NCNBSS) with the
establishment of the Centers for Human Genetics Services (CHGS).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Allocation
and utilization of a portion of the ENBS funds for the operation of the CHGS
and for the management (diagnostics and therapeutic) of patients. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SCOPE OF
APPLICATION</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall apply to all DOH –
Centers for Health Development (CHD), Ministry of Health (MOH), Bangsamoro
Autonomous Region in Muslim Mindanao (BARMM), Newborn Screening Centers (NSCs),
Newborn Screening Reference Center (NSRC), Institute of Human Genetics, Newborn
Screening Facilities (NSFs), and all other agencies and stakeholders concerned
in the implementation of the newborn screening program.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF
TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Advisory
Committee on Newborn Screening (ACNBS)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to the body created as an
integral part of the Office of Secretary of the DOH to ensure sustained
inter–agency collaboration. It is tasked, among others, to review and recommend
the standard NBS Fee to be charged by NSCs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Acute
Crisis</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to acute episode of illness caused by accumulation of toxic
metabolites which may be precipitated by catabolic stress such as infections,
fasting, or events surrounding the perinatal period. This may manifest with a
variety of symptoms depending on the specific disorder, but may involve poor
feeding, altered conscious state, seizures, acidosis or ketosis, respiratory distress,
and circulatory failure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Center
for Human Genetic Services (CHGS)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to a facility that covers
island–wide services (Luzon, Visayas, Mindanao) and facilitates comprehensive
clinical evaluation, appropriate services to families or individuals with
genetic conditions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Confirmatory
Center</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to a facility identified by the DOH to be part of the National
Comprehensive Newborn Screening System – Treatment Network, equipped to do
confirmatory testing to ensure the accuracy of screening results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Dietary
supplements</span></b><span style="font-family: "Palatino Linotype", serif;">
– refer to vitamins, minerals, amino acids or other nutrients intended to
provide nutrition, enhance the removal of accumulated toxins or facilitate the
function of a metabolic process (e.g., carnitine for organic acidurias and
carnitine uptake defect; and biotin for biotinidase deficiency).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Genetic
Services</span></b><span style="font-family: "Palatino Linotype", serif;">
– refer to services (i.e., genetic counselling, metabolic nutrition
counselling, clinical consults for evaluation and management reviews, etc.)
provided to patients confirmed to have metabolic disorders, birth defects and
other genetic disorders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Goods
</span></b><span style="font-family: "Palatino Linotype", serif;">–
refer to medications, medical food, dietary supplements, and highly specialized
medical supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Medical
Food</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to food used for therapeutic purposes specially formulated and
intended for the dietary management of a disorder that has distinctive
nutritional needs that cannot be met by normal diet alone (e.g.,
phenylalanine–free milk).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Medications
</span></b><span style="font-family: "Palatino Linotype", serif;">–
refer to medicines that may or may not be available commercially but essential
for treatment; thus, prescribed by the Pediatrician or Specialist to address
specific medical issues of patients with metabolic disorders. Treatment
quantity and duration may vary according to the prescription of the
Pediatrician or Specialist.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">National
Comprehensive Newborn Screening System – Treatment Network</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to a
network wherein total management of patients with confirmed diagnosis shall be
referred to. It follows the DOH approved clinical protocol in the management of
patients diagnosed in any of the disorders included in the newborn screening
panel.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">National
Institute of Health – Institute of Human Genetics (NIH – IHG)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to the
unit at the National Institute of Health that provides comprehensive clinical
evaluation of families or individuals with or at risk of heritable conditions;
it provides support for remote, real–time referral (the Telegenetics Referral
System and Birth Defects Surveillance System) in the country. It also offers
laboratory and diagnostic services pertinent to the management of heritable
conditions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">12.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Center (NSC)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to a facility equipped with a newborn
screening laboratory that complies with the standards established by the
National Institute of Health and the DOH and provides all required laboratory
tests and recall/follow–up programs for newborns with heritable conditions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">13.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Continuity Clinic (NBSCC)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to an ambulatory clinic based
in a tertiary hospital identified by the DOH to be part of the National
Comprehensive Newborn Screening System Treatment Network, equipped to
facilitate continuity of care of confirmed patients in its area of coverage.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">14.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Facilities (NSFs)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to institutions (i.e., hospitals, birthing
facilities, sanitaria, infirmaries, rural health units, and health centers)
offering newborn screening services such as, but not limited to, motivation of
parents, collection of blood sample and recall.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">15.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Reference Center (NSRC)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to the central facility at the
National Institute of Health that defines testing, and follow – up protocols,
maintains an external laboratory Proficiency Testing program, oversees the
national testing database and case registries, assists in training activities
in all aspects of the program, oversees content of educational materials and
acts as the Secrtariat of the Advisory Committee on Newborn Screening (ACNBS).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l20 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">16.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">PhilHealth
Enhanced Newborn Care Package (NCP)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to the PhilHealth benefit
package released on 21 Decemeber 2018, which includes full coverage of the ENBS
fee of Php 1,750 in the NCP. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l6 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Expanded
Newborn Screening shall be offered in all NSFs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l6 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
number of disorders in the expanded newborn screening panel shall be
twenty–eight (28) and more falling under various types of disorders namely:
hemoglobinopathies, amino acid disorders, organic acidurias, disorders of fatty
acid oxidation, disorders of carbohydrate metabolism, disorders of biotin metabolism,
cystic fibrosis, and endocrine disorders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l6 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NCNBSS – Treatment Network for the expanded newborn screening shall be
maintained in strategic areas of the country.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l13 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Confirmatory
centers that provide confirmatory testing following a positive screen and
follow–up of diagnosed individuals shall be maintained and the list of
confirmatory centers to be provides by NSRC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Confirmatory Testing Fund allocation,
form the NSCs and CHD shares on portion of the ENBS Fee, shall be used for
confirmatory testing of conditions included in the newborn screening panel.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l13 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
CHGS shall be established and will cover island – wide services (Luzon,
Visayas, and Mindanao). It shall facilitate comprehensive clinical evaluation,
appropriate diagnostic and therapeutic management, and genetic counselling
services to families or individuals confirmed to have a disorder included in
the ENBS panel.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l13 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Continuity Clinics (NBSCCs) established as per A.O. No. 2014 – 0035
shall be added in strategic areas of the country to facilitate and increase
access to long term care of patients confirmed through newborn screening.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l13 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Experts
committees on ENBS panel of disorders shall be created and maintained to
provide new information on the disorders, participate in the review of datasets
and cutoffs of the disorders, propose research agenda and recommend inclusions
of new disorders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l6 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Information,
education, and communication on the expanded screening and the disorders
included shall be made available to health professionals, parents, and the
general public at all NSCs, DOH – Central Office, DOH – CMDs, MOH – BARMM, and
Newborn Screening Facilities through multi – media in collaboration with the
DOH – HPCS and NSRC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l6 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Center preparations shall include laboratory renovations to meet
accreditation standards, procurement of equipment and reagents, hiring and
training of personnel, upgrading of database, preparation of manuals and
protocols, and implementation of other necessary program groundwork and shall be
undertaken in line with the strategies enumerated in the National Policy and
Strategic Framework on Expanded Screening for 2017 – 2030. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Establishment
of CHGS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l21 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">National
Institute of Health – Institute of Human Genetics (NIH – IHG) shall establish
the CHGS of the Newborn Screening Program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l21 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NIH – IHG shall have administrative and operational oversight of all CHGS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l21 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NIH – IHG shall serve as the CHGS for Luzon. It shall establish satellite CHGS
in Visayas, Mindanao and other centers in the future.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l21 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
CHGS shall be manned by a core team composed of Clinical Geneticist,
Pediatrician or Family Physicians, Nurse, Dietitian/Nutritionist, Pharmacist,
Genetic Counselors, Psychologists, Social Worker, and Administrative Staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Roles
and Responsibilities</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To ensure implementation of expanded
NBS, the agencies/organization identified below shall have the following
responsibilities:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">The
Department of Health</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l19 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Department of Health, through the Disease Prevention and Control Bureau –
Children’s Health Development Division (DCPB – CHDD) shall be the lead agency
in the implementation of ENBS. Its roles and responsibilities are stated in Section
13 of the Implementing Rules and Regulations of RA 9288. The DPCB – CHDD shall
also be responsible in reviewing/updating the guidelines periodically at least
3 years or sooner if there are new developments in the program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l19 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Health Promotion and Communications Service (HPCS), in coordination with the
NSRC, shall be responsible for advocacy and information dissemination on
expanded newborn screening to the communities throughout the country.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l19 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Health Facilities and Services Regulatory Bureau (HFSRB) shall ensure health
facilities applying as newborn screening facilities shall comply to the minimum
regulatory standards set by the DOH in the provision and delivery of quality
maternal and newborn care services. Further, it shall enforce the fines and
other penalties as contained in issuances concerning ENBS fees and the like.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l19 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Health Facility Development Bureau (HFDB) shall assist in the identification of
facilities or institutions that will qualify as the Newborn Screening Centers
in the other parts of the country where the services. It shall integrate and
update relevant aspects of establishing and developing NSCs all over the
country. Further, the HFDB shall provide technical inputs in the further
development of these NSCs in various joint workshops of the NSRC and DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Centers
for Health Development shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
in the implementation of expanded newborn screening</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Collaborate
with relevant stakeholders; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Allocate
funds for expenses related to monitoring of patients and adherence to medical
management and continuity care where needed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Philippine
Health Insurance Corporation (PhilHealth) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Include
the full coverage of the ENBS in the PhilHealth Newborn Care Package,</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Issue
circulars defining the new policies and procedures on the enhancement of the
Newborn Care Package, particularly ENBS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Revise
the coverage of the current Newborn Care Package based on the recommendations
from the Health Technology Assessment Council.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Facilities shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l11 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that expanded newborn screening is offered; and</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l11 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
information, education, communication, screening, recall and management of
identified cases and other related services, as outlines in Section 14 of the
IRR of R.A. 9288.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Reference Center shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
the guidelines for the establishment of the NSCs, NBSCCs, CHGS, and other
health facilities that will be relevant to the implementation of the ENBS
Program, to include but not limited to personnel requirements (for hiring and
renewal) and laboratory accreditation requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Define
the testing and follow–up protocols for the additional disorders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain
an external laboratory proficiency testing program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Integrate
the additional disorders in its case registries and national testing database.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
in training activities in all aspects of the NBS program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Handle
the legal requirements for the remittance, allocation, and transfer of fund
with NSCs and with NIH – IHG.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Determine
the appropriate allocation of funds for confirmatory testing and
management/treatment based on the prevailing costs in coordination with DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l17 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
program monitoring in coordination with the Department of Health.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">NIH
– IHG shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish
and oversee the operations of CHGS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate
the procurement and distribution of goods needed by the NSCs and the CHGS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
to NSRC the annual funding proposal for the procurement and distribution of
specific goods needed and the operations of CHGS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
quarterly reports to NSRC on procured and required medicines for CHGS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l16 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
consolidated reports of CHGS to NSRC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Centers
for Human Genetics Services shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate
comprehensive clinical management and genetic counselling services for families
and individuals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
NSCs, NSFs, and NBSCCs in the acute and long–term management of patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Serve
as the central repository of medical foods, orphan drugs and products and other
treatment needs not readily available locally and/or commercially.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
the distribution of medical foods, supplies, drugs to NSCs and NBSCCs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
research that shall contribute evidence – based data for direct strategic plans
of the National Comprehensive Newborn Screening System program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Collaborate
with NIH – IHG in developing management guidelines and other related advocacy
materials targeting relevant stakeholders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
periodic reports to NIH – IHG.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
NSRC in its capacity building among health personnel of NBSCCs among others.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Centers shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that personnel, laboratory space, equipment and supplies needed for the
implementation of the expanded newborn screening are in place.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that the mechanism for ordering and payment of expanded newborn screening
service is in place.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Strictly
follow the prescribed guidelines of good laboratory practices.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish
an appropriate financial and inventory system that shall ensure effective and
efficient distribution of goods to patients with metabolic disorders in acute
crisis.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that patients identified positive in any of the disorders are followed up, confirmed,
and referred to Specialists for initial management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Remit
funds to NSRC for treatment and for CHGS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Allocate
funds for monitoring, appropriate diagnostic, and therapeutic management, and
confirmatory of patients where necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
with CHGS on the management of patients needing further diagnosis and/or
management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l9 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Endorse
confirmed patients to the NBSCCs for continuity care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l8 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Continuity Clinics (NBSCCs) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate
continuous care of confirmed positive patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
long–term follow–up care activities related to improving care delivery,
including engagement of affected individuals and their families.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
periodic distribution of goods to patients seen at the continuity clinic.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
proper storage of goods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain
buffer stock and record of goods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
with the CHGS on provision of long–term management of their patients, including
supply of medical food and orphan drugs/products.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
monitoring data and surveillance of patients to NSRC and DOH for policy
development.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Schedule
genetic counselling sessions for the parents and other family member, either
face–to–face or Telegenetic counselling.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
periodic reports to CHGS on the agreed indicators for quality care of patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
quarterly reports to NSRC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Budget
Source</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">The
NBS Fee</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l5 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
adjusted ENBS Fee shall be Php 1,750 (per recommendation of the Advisory
Committee on Newborn Screening on 04 October 2018).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l5 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
PhilHealth members the total ENBS of Php 1,750 shall be covered.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l5 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">ENBS
shall have an allowable charge of Php 50 for the collection of the sample (DOH
A.O. No. 2005 – 005).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l5 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Overpricing
of newborn screening fees shall be reported to the Department of Health –
Health Facilities and Services Regulatory Bureau (HFSRB). The administrative
fines shall be imposed on health facilities that collect more than the maximum
allowable NBS fees (DOH A.O. 2008 – 0026 – A):</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l14 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">1<sup>st</sup>
Offense – Warning <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l14 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">2<sup>nd</sup>
Offense – administrative fine of fifty thousand pesos (Php 50,000) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l14 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">3<sup>rd</sup>
Offense – administrative fine of one hundred thousand pesos (Php 100,000)</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l0 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Usage
of NBS Fee</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">As
stated in Section 22 of the Implementing Rules and Regulations of R.A. 9288,
“Guidelines on the usage of funds, as approved by the ACNBS, shall be
formulated by the NIHP and DOH. The NBS shall be applied to among others
testing costs, education, sample transport, follow–up and reasonable overhead
expenses.”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
treatment fund is a portion of ENBS fee that shall be allocated to augment the
cost of treatment and management of patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NSRC shall prepare a Memorandum of Agreement (MOA) with NSCs and NIH – IHG for
the allocation and transfer of funds from NSC which shall in turn be
transferred to IHG for the procurement of medicines, medications, and
medical/surgical management for patients from all NSCs and the operation of
CHGS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">NSCs
shall a lot:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l12 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Php
200 per patient screened intended for treatment fund, and facilitate quarterly
transfer of treatment fund to NSRC based on actual collection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l12 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Php
30 per patient screened intended for operations of the CHGS, and facilitate
quarterly transfer of fund to NSRC based on actual collection. The budget for
the CHGS operations shall include Personnel Services, Maintenance and Office
Operation Expenses and Capital Outlay (e.g. space rental, renovation, office
equipment, etc.).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Treatment Fund support shall also be provided for initial (one–time) acute
crisis management. This shall be limited to emergency medical procedures (e.g.,
peritoneal dialysis, central line placement), medications, medical food,
dietary supplements, and highly specialized medical supplies. This shall not be
convertible to cash.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
assistance to patients shall be subject to availability of funds.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
disbursements of funds shall be subject to existing accounting and auditing
rules and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Reporting
and Monitoring Protocols</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">An evaluation plan shall be implemented
that would clearly define selected indicators, assign responsibility for
monitoring, and outline the periodicity with which evaluations are to occur.
The program evaluation shall encompass the detailed procedures, operational
arrangement, performance evaluation of program implementers, and fund
management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Operational details of the CHGS
operations and Treatment Fund shall be incorporated in the MOA, Department
Circulars, and/or Manual of Operations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REPEALING/SEPARABILITY
CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">A.O. No. 2014 – 0045, 2014 – 0045 – A
and other issuances that are inconsistent are hereby repealed/rescinded. If any
provision of this Order is declared invalid, the other provisions not affected
thereby shall remain valid and subsisting. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall take effect fifteen
(15) days after publication in a newspaper of general circulation. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO
T. DUQUE, III, MD, MSc<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary
of Health</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-27996287582603979822023-05-24T19:34:00.000+08:002023-05-24T19:34:37.896+08:00Administrative Order No. 2022 – 0035<p><span style="color: #01ffff; font-size: large;"> </span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">22
AUGUST 2022<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: x-large;"><b><span style="font-family: "Palatino Linotype", serif;">GUIDELINES IN
THE IMPLEMENTATION OF DIFFERENTIATED</span></b><span style="font-family: "Palatino Linotype", serif;"> <b>HIV TESTING SERVICES</b></span></span></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><b><span style="color: #01ffff; font-size: large;"><br /></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Philippines has maintained the Human
Immunodeficiency Virus (HIV) prevalence rate at less than 1%, however, it has
been noted that there has been a 207% increase in new HIV infections from 2010
to 2019, disproportionately affecting key populations. While 70% (78,921) from
the estimated 111,400 people living with HIV (PLHIV) in the country have been
diagnosed, 30% (33,109) were still undiagnosed as of December 2020 with limited
testing options identified as one of the key issues in the diagnosis gap based
on the 2019 HIV Joint Program Review (JPR).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To bridge the diagnosis gap, the
Philippine Health Sector – HIV Strategic Plan (HSP) 2020 – 2022, deeply rooted
in the Republic Act No. 11223 Universal Health Care Act and the DOH FOURmula
ONE, HIV testing options made available at the primary care level as one of its
key strategies to achieve its targets. This strategy which includes peer–led or
community–based screening (CBS), health worker–led or facility–based testing,
self–testing, social and sexual network testing (SSNT), and the intimate
partner testing. These various approaches in HIV testing are underpinned by
multi–sectoral action and empowered people and communities to ensure
integration of HIV–related services into the primary care package.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Demonstration projects on self–screening
have shown high uptake among males who have sex with males (MSM) and
transgender women (TGW). In Metro Manila, it showed 8.04% reactivity rate of
which 37.2% were first–time testers. In Western Visayas, a 9.2% reactivity rate
was reported whereby 50% were first–time testers. Further, SSNT has high
uptakes in four community centers with a 3% reactivity rate and an average of 1
recruiter to 30 key populations client referrals tested. This Administrative
Order is developed to increase HIV diagnosis to 95% by reaching out to key
populations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Administrative Order is issued to
provide technical, programmatic, and operational guidance in the implementation
of HIV Testing Services in health facilities and guidance for HIV clients in
the Philippines. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SCOPE OF
APPLICATION</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Order shall apply to DOH hospitals,
Centers of Health Development (CHDs), Local Government Units (LGUs), and all
service providers, coordinators, heads, or managers of facilities offering HTS
in public and private settings, including community–based organizations (CBOs)
or key population–led facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In the case of Bangsamoro Autonomous
Region in Muslim Mindanao (BARMM), the adoption of this Order shall be in
accordance with R.A. 11054, otherwise known as Bangsamoro Organic Act and the
subsequent laws and issuances to be issued by the Bangsamoro Government. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF
TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Adverse
event</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to an incident that results in harm to the client or others because of
their participation, including both intended and unintended cause of physical,
economic, emotional, or psychosocial injury or hurt occurring before, during,
or after HTS from one person to another, to oneself, and/or an institution to a
person.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Children
in Need of Special Protection</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to children living alone, co–habitating, primary worker of the family, engaged in transactional sex,
disowned due to discrimination based on their sexual orientation, gender
identity and expression (SOGIE) and/or sexual characteristics, sexually active,
or in other similar situations that expose them to risks of HIV infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
reach</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to the active participation of clinicians and other healthcare
providers in the clinical setting to offer HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Combination
prevention</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to the strategic use of different options for HIV prevention, which
include but are not limited to non–occupational and occupational post–exposure prophylaxis (PEP), <a href="https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis/" target="_blank">pre–exposure prophylaxis (PrEP)</a>, condoms and
lubricants, substance–related harm reduction, safe needle, and syringe
practices, and/or treatment of HIV–positive partners.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Community
outreach</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to testing activities that reach to many people, including those who
live far from a testing facility or those who are working that may not have the
time to visit a testing facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Community–based
HIV Screening (CBS)</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to a non–laboratory rapid HIV screening procedures performed by a
trained healthcare provider or a member of community–based organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Facility–based
HIV testing</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to testing performed in accredited facilities to determine the presence
of antigen and/or antibody against HIV. These facilities may include (1)
laboratory facility–based testing (LFBT), in a licensed laboratory, which can
either be certified rHIVda confirmatory laboratory (CrCL) or non–CrCL, and (2)
non–laboratory facility–based testing (NLFBT), which refers to facilities other
than licensed laboratories performed by other trained healthcare worker, which
can include provider–initiated counselling and testing (PICT).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Self Testing</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to a process in which a person collects their own specimen, often in a
private setting, either assisted or unassisted, then performs a test using DOH
FDA–registered HIV test kits and interprets the result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to any procedure used to identify the presence or absence of HIV
infection, which includes test for triage or HIV screening, laboratory facility– based testing, mobile procedures, and other approaches.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
Testing Services</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to a broad range of services that shall be provided alongside HIV
testing, including counselling, linkage to necessary and appropriate HIV
prevention, treatment, and care, and other clinical support services and
coordination with stakeholders to support quality assurance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">K.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Index
client</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to a diagnosed PLHIV, who is enrolled or returning in HIV care
services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">L.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Index
Testing (IT)</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to offering HTS to sexual partners, injecting partners, and biological
children and parents of known PLHIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">M.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">In–reach</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to
offering HTS to partners and peers, colleagues, networks, and communities with
common interests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">N.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Key
population</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to sex workers, men who have sex with men, transgender women, people
who inject drugs, and people in prison and other enclosed settings.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">O.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Mature
Minor Doctrine</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to the legal principle that recognizes the capacity of some minors to
consent independently to medical procedures if they have been assessed by
qualified health professionals to understand the nature of procedures and their
consequences and to decide on their own.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">P.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Sexual
and social network Testing (SSNT)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to a process where a trained
provider asks a PLHIV or key population client who tested negative but with
continuous substantial risk for HIV to motivate and invite other people in
their sexual or social networks to engage in voluntary HIV testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">Q.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Social
Network</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to a group of people brought together by a similar characteristic, set
of relationships, or behaviours, including sexual and drug – injecting/using
partners.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">R.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Testing
for Triage (T0)</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to initial screening tests done outside CrCL using Department of
Health (DOH) Food and Drug Administration (FDA)–registered rapid diagnostic
kits which can be performed by oneself and/or by a trained and supervised
healthcare worker or lay person.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l33 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">S.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Virtual
reach</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to the use of digital platforms to increase efficiency of HTS through
providing approaches simulated online. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l11 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provision
of HTS shall observe the fundamental principles of human rights as it relates
to universal health care and gender equality which includes but not limited to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Right
to self–determination <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Right
to informed consent <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Right
to privacy and confidentiality<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Right
to information <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Right
to choose a health provider <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Right
to be informed of patient rights and obligations</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l11 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
of HTS shall be based on the Philippine HIV and AIDS Policy Act (R.A. 11166),
Universal Health Care Act (R.A. 11223), Data Privacy Act of 2012 (R.A. 10173),
Responsible Parenthood and Reproductive Health Act of 2012 (R.A. 10354), and
Special Protection of Children Against Abuse, Exploitation and Discrimination
Act (R.A. 7610), and subsequent related issuances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l11 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Integration
of multiple approaches of HTS (see Annex A) shall be based on the capacity of
service providers, facilities, or organizations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l11 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Informed
consent shall be obtained form all HTS clients through written, electronic, or
recorded means. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Demand
Generation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Healthcare
workers, CBOs, volunteers, public and private health facilities, including key population–led
service facilities shall work closely to promote knowledge sharing and improve
the awareness of KPs and their access to testing modalities that fit their
needs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
communication platforms shall be explored to identify demand and educate key
populations on the available HTS in the country, specifically emphasizing the
importance of knowing HIV status.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HCWs, CBOs and volunteers shall work with key population–led health services,
reproductive health, and wellness centers (RHWC) and other HIV treatment
facilities to ensure access of key population clients to HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l18 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
every circumstance, proper counselling shall be conducted by a social worker, a
healthcare provider, or other health care professional accredited by the DOH or
the DSWD.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Informed
Consent</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Consent
for HIV testing shall be obtained from the client 15 years old and above
through written or electronic consent (see Annex C.1).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Consent
will be allowed either written or electronically complied.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Any
young person below fifteen (15) years who is pregnant or has engaged in
high–risk behaviour shall be eligible for HIV counselling and testing with the
assistance of a licensed and trained social worker of health worker and consent
shall be obtained from the person without the need for consent from a parent or
guardian, based on the R.A. 11166.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
all other cases not covered above, consent to HIV testing for minors shall be
obtained from the parents or legal guardians of infants or children born to HIV
positive mothers, persons below 15 years old, or is mentally incapacitated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l27 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Proxy
consent shall be obtained from the licensed and trained social worker or health
worker in cases when:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
child parent or legal guardian cannot be located despite seven (7) working days
of reasonable efforts or refused to give consent pursuant to Section 29 of
Republic Act No. 11166.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
child has been voluntarily or involuntarily under the protective custody of the
Department of Social Welfare and Development (DSWD).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
child has been living with the family, guardians, or relatives but with admission
of abuse, neglect, and/or exploitation from any member of the family/household.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
child is categorized under Children in Need of Special Protection by R.A. 7610.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l15 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(5)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assent
of the minor shall be required prior to any HTS procedure to protect their best
interest and consider their evolving capacity.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Although
verbal consent from clients 15 years old and above is adequate in CBS and ST,
securing written or electronic consent shall be preferred.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Differentiated
Approaches in HIV Testing Services</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l40 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Facility–based
HIV Testing (FBT)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Any
client who initiates accessing the following services shall be routinely
offered HTS:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Antenatal
and Postnatal Care <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Tuberculosis
Management and care<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">HIV
prevention for key populations<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">People
in closed settings, including people deprived of liberty. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(5)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">STI
and HIV diagnosis and management<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(6)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Reproductive
health and wellness <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(7)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Viral
hepatitis <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(8)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Adolescent
clinics</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Adults,
adolescents, and children with symptoms or apparent presence of indicator
conditions (See Annex C.2) suggesting HIV infection, or those with risky
behaviours, shall be offered HTS through provider–initiated counselling and
testing (PICT) in clinical settings. PICT can be provided by trained healthcare
providers, which include but are not limited to Physicians, Nurses, and
Midwives.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
HIV–exposed infants shall be tested for HIV in accordance with A.O. 2018 –
0024: Revised Policies and Guidelines on the Use of Antiretroviral Therapy
(ART) among People Living with Human Immunodeficiency Virus (HIV) and
HIV–exposed infants.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">HIV
proficiency training is no longer required for HIV testing, but identified
rHIVda training requirement remains for CrCL [refer to A.O. 2019 – 0001:
Guidelines on the Implementation of Rapid HIV Diagnostic Algorithm (rHIVda)]</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l26 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">See
Annex D for the detailed FBT guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l40 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Community–based
HIV Screening (CBS)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">This
service shall be provided to key populations at the community or closed
settings and shall be implemented based on the Department Memorandum (DM) 2020 – 0276, or the Interim Guidelines on
Community–based HIV Screening. Additional information on provision of CBS is
indicated in (Annex E).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l40 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Self–Testing
(ST)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">This
service shall be offered to high-risk key population clients who would not
otherwise access HTS in the community or facility settings and who would prefer
to collect specimens, perform the tests, and interpret the result either alone
(unassisted) or with a trained provider or peer (assisted).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Results
of unassisted and assisted self–testing will be consolidated and will be
referred to a treatment hub or rHIVda site for repeat and confirmatory testing,
care, and treatment if reactive, refer to combinations prevention if
non–reactive and advise re–testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Additional
information on provision and access to ST are detailed in Annex F.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l40 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Index
Testing (IT)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">This
service shall be offered and shall be made voluntary to the sexual partner(s)
of PLHIV considering the needs and safety of the index client and their
partner(s).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Biological
infants and young children of PLHIV and whose HIV status is unknown shall be
offered HTS through provider–assisted index testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
PLHIV shall be assured of continued HIV services regardless of their decision
to participate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
providers offering IT shall adhere to minimum safety and ethical standard
requirements for the conduct of IT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l25 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">See
Annex G for detailed guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l40 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Social
and Sexual Network Testing (SSNT)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">This
service shall be offered to all persons, regardless of HIV status, coming from
networks with substantial risk for HIV to motivate and invite other people in
their sexual or social networks to engage in voluntary HIV testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">SSNT
shall be integrated in other services like STIs, Tuberculosis, and Hepatitis B
and C.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Safety
and privacy of clients shall be ensured when offering SSNT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">See
Annex H for detailed SSNT guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Conduct
of HIV Testing Services</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
conduct of HTS shall include the following components: (a) mobilization; (b)
testing; and (c) linkage to appropriate services. For the HTS framework, see
Annex A.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Mobilize
through different forms of reach, which include in–reach (through SSNT and IT),
community outreach (through ST and CBS), clinical reach (through FBT), and virtual
reach as entry points for HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Testing
for triage (T0) through FBT, CBS, or ST, or T1 if in CrCl shall ensure
provision of pre–test information and obtaining consent prior to testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Each
approach shall follow procedures based on their respective specific guidelines
(For FBT, see Annex D; for CBS, see DM 2020 – 0276: Interim Guidelines on
Community Based Screening; and for ST, Annex F).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Post–test
counselling (Annex I) shall be provided and linkage to appropriate services
shall be ensured once the result is available.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Official
copy of non–reactive T0 written results (T1, if CrCL) shall only be available
in LFBT duly signed by a registered medical technologist who performed the test
and validated by a Pathologist. For RHWC and TB Services facilities without a
Pathologist, the supervising Physician shall review, validate, and countersign
the result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l22 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Unofficial
reactive T0 results can be provided in FBT upon client’s request; however, it
shall be indicated that this is not a confirmed HIV diagnosis and confirmatory
testing is yet to be performed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Link
clients to appropriate services based on the result to T0</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l19 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Clients
with non–reactive T0 results shall be referred to appropriate services
including retesting, SSNT, combination prevention services, and other ancillary
services based on the needs of the client.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l19 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Clients
with reactive T0 results shall be referred to an HIV treatment facility for
linkage to confirmatory testing and care using an official referral form (Annex
C.3) or by accompanying the client, if applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l30 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV treatment facility which receives referred clients with initial reactive
results shall repeat HIV testing within one week for the purpose of validation.
Specimens shall be sent immediately to its designated CrCL or NRL – SLH/SACCL
for confirmatory testing only if it has not been previously sent. If not done
timely, the specimen shall be refrigerated and sent within one week of
extraction.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l30 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
cases when treatment facilities receive clients with confirmed positive
results, the facility may repeat HIV testing if deemed necessary before
initiating ART.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l30 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
receiving HIV treatment facility shall perform clinical assessment and further
management despite pending confirmatory results; clients shall be linked to
treatment and care services, which include immediate initiation of ART,
preferably same–day ART (in accordance with the national HIV treatment
guidelines), effective and appropriate follow – up, case management, and
continuous adherence counselling.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l30 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
official confirmatory test results shall only be released to the referring
facility by the CrCL or by the NRL – SLH/SACCL to ensure that the release of
HIV confirmatory tests is accompanied by post–test counselling (see Annex I).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l30 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(5)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Once
the confirmatory test results are available, it is an ethical obligation of the
treatment facility provider to check the test result is consistent with the
label on the envelope and with that of the identified client. Upon verification
of the result, they shall contact the client for further counselling and
release of confirmatory test results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l30 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(6)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
treatment facility provider shall release the official copy of the confirmatory
test results informing the client of the result simply, clearly and in an
objective manner, and provide ample time to allow them to absorb the
information via print or secured email.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l30 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(7)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
further counselling (Annex I) and appropriate services based on the
confirmatory test results:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126.0pt; mso-list: l37 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If confirmatory test is positive:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 144.0pt; mso-list: l2 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(a)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">CrCl
and NRL – SLH/SACCL are required to report HIV positive results to the EB of
the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 144.0pt; mso-list: l2 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(b)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Continue
medical management consistent with the national HIV treatment guidelines, case
management, and counselling.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 144.0pt; mso-list: l2 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(c)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Offer
IT and/or SSNT</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126.0pt; mso-list: l37 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If the confirmatory test is
negative, the treatment facility shall perform the recommendations from the
confirmatory laboratory as indicated in the confirmatory result, if there is
any.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126.0pt; mso-list: l37 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If the confirmatory test is
inconclusive, in cases that confirmatory laboratories will release such test
results to the referring facility, the latter shall perform either (1) the
recommendations of the national reference laboratory as indicated in the
confirmatory result or (2) recommendations of Annex 1 of A.O. 2019 – 0001.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l19 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
clients with invalid or inconclusive T0 results, further services shall be
provided based on the specific guidelines of FBT (Annex D), CBS (Annex E) and
ST (Annex F).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l19 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
clients shall be referred to auxiliary services based on the needs of the
client, which may include other sexual health services, mental health services,
substance related harm reduction, and gender affirming services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l32 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
clients who disclosed sexual abuse, they shall be referred for clinical and
psychosocial management and redress services. If reported within 5 days of
occurrence, minimum clinical management include first – line support, HIV
post–exposure prophylaxis (PEP) (if within 72 hours of sexual contact), STI
presumptive treatment or prophylaxis, and other reproductive health–related
services.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Retesting</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l28 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HTS provider shall advise the clients for retesting and contact them to notify
retesting if they previously consented to provide their contact information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l28 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Individuals
who tested non–reactive and reported recent high–risk behaviour shall be
retested at 4 weeks after the last HIV test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l28 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Individuals
presenting with STI or viral hepatitis, or those with recent HIV risk exposure
shall be retested after 3 months from the last HIV test and then every 3 months
for those with ongoing high–risk behaviour, especially as part of broader HIV
prevention services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l28 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Casual
or intimate partners of PLHIV and key populations shall be retested for HIV
annually.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l28 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Pregnant
women who belong to key populations or partners of a PLHIV with unsuppressed VL
shall be retested once in the first trimester (along with testing for HBsAg and
Syphillis), once in a third trimester, and once postpartum (14 weeks, 6 months,
or 9 months postpartum).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l28 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
all other pregnant women, consider retesting during 3<sup>rd</sup> trimester
and postpartum (14 weeks, 6 months, or 9 months postpartum) if with an ongoing
high risk of transmission.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l28 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Clients
with indeterminate or inconclusive rHIVda results shall be retested in
accordance with rHIVda guidelines (refer to A.O. 2019 – 0001)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">MONITORING
AND EVALUATION</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l29 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
ensure that HTS programs reach their intended population and identify
previously undiagnosed HIV infections, the National HIV, AIDS and STI
Prevention and Control Program (NASPCP) shall perform regular monitoring and
evaluation and quality assurance and continuous quality improvement.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l29 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">HTS
Training on different modalities shall be delivered to providers of varied
cadre.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l29 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conducting
an in–depth HTS situational analysis shall be done prior to optimizing HTS
approaches. It shall also include a review of complementary packages of
services to facilitate linkage to appropriate services, demand generation
approaches for HTS, and its effectiveness.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l29 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Shared
Ownership of Data</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l34 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Securing
clients’ personal data shall adhere to the protection provisions of R.A. No.
10173 Data Privacy Act of 2012 and its IRR of 2016.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l34 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
HTS providers involved in the implementation of any of the HTS delivery
approaches shall observe proper documentation and report for monitoring and
evaluation purposes.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l34 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Implementers
may opt to keep copies of the reports and forms if all the following conditions
are met:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
implementer fully understands the provisions of R.A. 11166 on confidentiality
and R.A. 10173 on data privacy.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
implementer can provide a secured storage for the files.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Access
to these files is limited to the HTS staff and the EB.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l17 level1 lfo27; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Test
logs and other forms containing the client’s real name and personal information
may only be kept by HTS providers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l29 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
approach–specific indicators (see corresponding annexes) shall always be
disaggregated in terms of geography, demographics, and particular population
group (key population and their partners, pediatric and adolescent, pregnant).
These shall be used to inform national – level indicators:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Number
of PLHIV who know their status.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Number
of key population clients tested for HIV and positivity rate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Number
of clients reached virtually.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l29 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">While
internal assessments shall be done through internal auditing by site
supervisors and mentorship and supervision visits, there shall, likewise, be
external assessments through mechanisms which may include licensing for
laboratories, External Quality Assessment Schemes (EQAS), and other HTS
accreditation processes. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">ROLES
AND RESPONSIBILITIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Disease
Prevention and Control Bureau (DPCB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Augment
resources of LGU to provide HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Continually
review and monitor the HTS Policies and Guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Formulate
plans and policies to improve HTS implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Forecast
and plant availability of HTS supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Inventory
of HTS supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l21 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
availability of HIV testing, prevention, and treatment commodities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Epidemiology
Bureau (EB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Collect
required data from regional and provincial epidemiology and surveillance units,
HIV testing sites, and CHDs, and provide the status of outcome of HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain
and update the HIV – AIDS & ART Registry of the Philippines (HARP) and the
One HIV – AIDS and STI Information System (OHASIS).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Validate
LGU data as needed through the Regional Epidemiology Surveillance Unit (RESU).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l36 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
quarterly updates on HIV/AIDS surveillance to the National HIV, AIDS and STI
Prevention and Control Program (NASPCP).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Health
Promotion Bureau (HPB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l24 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Implement
demand generation activities and other promotional strategies regarding HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Supply
Chain Management Service (SCMS) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Forecast,
monitor, and perform inventory of HTS supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Philippine
National AIDS Council (PNAC) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitor
programs and activities related to the implementation of R.A. 11166 and HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
Centers for Health Development (CHDs) and Ministry of Health – Bangsamoro
Autonomous Region in Muslim Mindanao (MOH – BARMM) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Collaborate
with CBOs and LGUs to ensure implementation of these guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate
capacity–building activities to implement the guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
mentorship and supervision in the implementation of HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Forecast
and Plan availability of HTS supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Manage,
resource, commodities, and supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Inventory
of HTS supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Strengthen
service delivery network for HTS and regularly update its directory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
testing sites’ compliance to certification and licensing requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
facilities’ compliance to accreditation requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l8 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Submit
HTS related reports to the Central Office.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">National
Reference Laboratory – STD AIDS Cooperative Central Laboratory (NRL – SACCL)
shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Improve
national confirmatory laboratory referral network.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
regular review of the national testing algorithm.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Mentor
HTS facilities on the development of site SOPs and job aids.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">CrCl
or facilities with rHIVda services shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo37; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
compliance as CrCL and license to operate (LTO).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l7 level1 lfo37; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain
close collaboration with NASCPCP, EB, Treatment facilities, LGU, and SACCL to
provide quality rHIVda service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">HIV
TH, PHCC, and HIV Testing Facilities shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l35 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Integrate
HTS in all relevant departments through the coordination of HACT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l35 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
compliance to recording and reporting on HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l35 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
internal monitoring and supervision to ensure provision of quality HTS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Local
Government Units shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Implement
HTS in various departments in hospitals, targeted communities, health centers,
RHU, RWHC, PHCC, TH and other HTS facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that infrastructure of the facilities implementing HTS are fully functional.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Support
and allocate funds for the implementation of quality control and participation
in EQAS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Inventory
of HTS Supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
appropriate resources to implement the guideline.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Employ
monitoring and supervision mechanisms to ensure adherence to guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">K.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Non–government
/ Community–based / Civil Society Organization shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Actively
engage in the development and implementation of HTS guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
in the dissemination of this policy.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Collaborate
and coordinate with LGUs in implementation of HTS guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
immediate linkage of HTS clients to appropriate services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
feedback to LGU and CBOs on the quality of HTS they provide.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
with local authorities for appropriate delivery of HTS services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">L.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Development
Partners shall be encouraged to:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l39 level1 lfo41; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
technical support for development of HTS – related resources and materials to
aid service providers in the implementation of the guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l39 level1 lfo41; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
in monitoring and evaluation of and mentorship and supervision to ensure
delivery of quality HTS service.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l39 level1 lfo41; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SEPARABILITY
CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">If any clause, sentence, or provision of
this Order shall be declared invalid or unconstitutional, the other provisions
not affected thereby shall remain valid and effective.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">X.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Administrative Order 2017 – 0019 or
“Policies and Guidelines in the Conduct of Human Immunodeficiency Virus (HIV)
Testing Services (HTS) in Health Facilities” and all other issuances
inconsistent or contrary to the provisions of this Administrative Order are
hereby repealed, amended, or modified accordingly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">XI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Order shall take effect after
fifteen (15) days following its publication in a newspaper of general
circulation and upon filing of three (3) certified copies to the University of
the Philippines Law Center. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">MARIA
ROSARIO SINGH – VERGEIRE, MD, MPH, CESO III<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Officer–In–Charge
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Department
of Health</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-11719195279175082882023-05-24T18:48:00.001+08:002023-08-07T15:06:51.634+08:00Administrative Order No. 2022 – 0007<p><span style="color: #01ffff; font-size: large;"> </span></p><p><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">01
March 2022</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;"><span style="font-size: x-large;">PHILIPPINE
STANDARDS ON THE RETENTION PERIOD OF DOCUMENTS, RECORDS, SLIDES AND SPECIMEN IN
CLINICAL LABORATORIES</span><span style="font-size: large;"><o:p></o:p></span></span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Cognizant of its role to provide an
effective and efficient Quality Management System (QMS) in Clinical
Laboratories and to set a framework to strengthen the development,
implementation, and evaluation of the health policies, programs, and plans by R.A. No. 11223 or “Universal Health Care Act,” the
Department of Health (DOH) promulgated this Order by providing a comprehensive
set of quality standards on the retention of documents, records, slides, and
specimens in Clinical Laboratories. In addition to the mandate of the National
Archives of the Philippines Act of 2007 to review and update all health
records, policies shall be developed to protect all public documents, records,
and other pertinent materials of archival value prior to its disposal. Thus,
meetings with the Technical Working Group (TWG) established through DPO 2018 –
1602 entitled “Creation of a TWG to Formulate AO on the Establishment of
Retention Period for Documents, Records, Slides, and Specimen in Clinical
Laboratory” were held to establish the national standards on the minimum
retention period referenced from international laboratory standards such as
temporary storage in accessible and suitable environment to ensure a secure,
safe–keeping repertoire. This also cites the recently issued Records
Disposition Schedule by the National Archives of the Philippines (NAP) date 26
May 2021.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Provisions under this Order comply with
the requirements stated in the assessment and inspection tool for the issuance
and renewal of license to operate (LTO) of clinical laboratories by the Health
Facilities and Services Regulatory Bureau (HFSRB) pursuant to A.O. No. 2021 –
0037, “New Rules and Regulations governing the Regulation of Clinical
Laboratories in the Philippines.” Further, this order also follows the roles
and responsibilities of the Office of Health Laboratories stipulated under D.O.
No. 2021 – 0421 entitled “Creation of the Office for Health Laboratories under
the Health Facilities and Infrastructure Development Team to Institutionalize
the Philippine Health Laboratory System,” pending the enactment of Center for
Disease Control and Prevention. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">General
Objective:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall provide guidance on the
national standards on the minimum retention period of documents, records,
slides, and specimens in all clinical and public health laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l15 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Specific
Objectives:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
establish retention period guidelines on documents, records, slides, and
specimens according to its storage conditions and to prevent overloading of the
storage capacity of laboratories; and</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">To
ensure compliance of retention protocols as part of the minimum standards and
inspection tool in licensing a clinical laboratory by HFSRB.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo3; text-indent: -18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SCOPE AND
COVERAGE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall apply to all clinical
and public health laboratories in the country, including government– and
private–owned, clinical and anatomic pathology, institution–based and
free–standing, general and special laboratory, primary, secondary, or tertiary
laboratories, and laboratories with limited-service capability.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF
TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l2 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
Laboratory</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to a facility that is involved in the (a) pre–analytical, (b)
analytical, and (c) post–analytical procedures, where tests are done on
specimens form human body to obtain information about the health status of a
patient for the prevention, diagnosis, and treatment of diseases. These tests
include but are not limited to the following disciplines: clinical chemistry,
hematology, immunohematology, microbiology, immunology and serology, clinical
microscopy, histopathology (cytology), toxicology, endocrinology, molecular and
nuclear diagnostics.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l2 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Documents</span></b><span style="font-family: "Palatino Linotype", serif;"> – refer to
written information regarding policies, processes, and procedures in the
clinical laboratory to communicate effectively to all laboratory staff and
users, which need to be updated or maintained when necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l2 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Records</span></b><span style="font-family: "Palatino Linotype", serif;"> – refer to the
collected information produced by the laboratory in the process of performing
and reporting laboratory tests that are permanent and are easily retrieved by
the laboratory staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l2 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Retention
Period</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to the specific period established by the DOH as the lifespan of
documents, records, slides, and specimens after which they are deemed ready for
permanent storage or disposal in accordance with the statutory and regulatory
requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l2 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Slides</span></b><span style="font-family: "Palatino Linotype", serif;"> – refer to thin
pieces of glass used to hold a portion of tissues or body fluids for
examination under the microscope.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l2 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Specimens</span></b><span style="font-family: "Palatino Linotype", serif;"> – refer to
portions of human body fluids or tissues taken for examination, study, or
analysis of one or more quantities assumed to apply.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l2 level1 lfo4; text-indent: -18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l11 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
DOH shall institutionalize the minimum standard retention periods of documents,
records, slides, and specimens in clinical laboratories in the country as
stated in Annex A of this Order and as guided by the approved Records
Disposition Schedule (RDS) by the National Archives of the Philippines as
disseminated through the Department Circular 2021 – 0226 entitled
"Dissemination of the Approved Records Disposition Schedule (RDS).”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l11 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
clinical laboratories shall establish their own archive to safeguard its
documents, records, slides, and specimens, including paraffin blocks, in a safe
environment, protected from loss and destruction and secured from theft and
tampering. For records, slides, and specimens classified for permanent
preservation, a repository shall be made available for permanent storage of
important data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l11 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Pursuant
to R.A. No. 10173 or the Data Privacy Act of 2012, all clinical laboratories
shall ensure privacy or confidentiality by allowing authorized personnel only
for clinical laboratory management on accessing laboratory documents and
records. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l0 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
clinical laboratories shall implement the guidelines on the retention period as
stated in this issuance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l0 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
clinical laboratories shall conduct a regular inventory of retained specimens
for the biosafety and biochemistry of the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l0 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
clinical laboratories shall create their own institutional policies and
procedures and adopt them to their respective Standard Operating Procedures
(SOPs) based on the minimum retention period of documents, records, slides, and
specimens as patterned to this order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l0 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
head of laboratory shall ensure institutional policies for all documents,
records, slides, and specimens are maintained and available for the time frames
as specified in this order if the Clinical Laboratory ceases its operation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l0 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
dedicated space in the health facility shall ensure for a suitable archive for
placement of documents, records, slides, and specimens within the premises or
an off–site area within the vicinity of the Clinical Laboratory, if it is
stated in their own internal policies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l0 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
DOH together with the NAP shall permit the use of electronic laboratory
documents and records if it is accessible and retrievable by the authorized
user.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l0 level1 lfo6; text-indent: -18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">ROLES
AND RESPONSIBILITIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l4 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Office
of Health Laboratories (OHL) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l13 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
technical assistance in the development and updating of standards on retention
period of clinical laboratory documents, records, slides, and specimens; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l13 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate
with HFSRB, NAP and the different clinical and public health laboratories in
implementing and updating this Order, as deemed necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l4 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Health
Facilities and Services Regulatory Bureau (HFSRB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l9 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Enforce
compliance to the retention period of documents, records, slides and specimens
and its manner of disposal during inspection of issuance or renewal of LTO of
clinical laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l4 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
and Public Health Laboratories shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l16 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Include
the provisions of this issuance in their respective SOPs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l16 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Adopt
the time for retention of their laboratory documents, records, slides, and
specimens based on Annex A of this issuance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l16 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
a suitable archive of documents, records, slides, and specimens within the
clinical laboratory premises as to prevent damage, deterioration, loss, and
misuse of clinical laboratory information pursuant to the Data Privacy Act of
2012.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l16 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Document
an inventory or reports of laboratory documents, records, slides, and specimens
periodically as part of their own SOPs; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l16 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Comply
with the standards of the retention period of documents, records, slides, and
specimens to ensure efficient and effective QMS in Clinical Laboratories and as
part of the requirements of issuance and renewal of LTO and inspection tool by
the HFSRB.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l16 level1 lfo10; text-indent: -18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall take effect fifteen
(15) days after publication the DOH, or in a newspaper of general circulation,
and upon filing of three (3) certified copies of this order with the Office of
the National Administrative Register of the University of the Philippines Law
Center.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO
T. DUQUE III, MD, MSc<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary
of Health</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="5" style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">LIST OF
RETENTION PERIOD BASED ON ITS CATEGORY</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td colspan="5" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l7 level1 lfo11; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">DOCUMENTS AND
RECORDS<o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td colspan="5" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l6 level1 lfo12; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Analytical Systems and Quality Improvement Files</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" valign="top" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Active<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Storage<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Total<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Remarks<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Annual
Review of Policies, Processes, and procedure records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Equipment
and Instrument Preventive Maintenance Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">After
equipment has been returned / rendered unserviceable<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inspection,
Audit and Assessment Records <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Management
Review Records <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Method
Manuals (Work Instruction) & Laboratory Worksheet <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td rowspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">After
procedure has been discontinued<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Method/Process
Validation Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Quality
Control Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Qualification
System Assessment and Proficiency Testing Records <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(e.g.,
NEQAS)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Reagent,
Materials and Supplies Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Specimen
Rejection Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1 year<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1 year<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Supplier
Qualification Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Waste
Disposal Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td colspan="5" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l6 level1 lfo12; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Clinical Laboratory Files</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Blood
Bank Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" valign="top" width="75">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Donor<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5
years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5
years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10
years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Recipient
and other patients <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5
years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5
years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10
years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Permanent
Deferral Donor<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 6cm;" width="227">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanent**<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Clinical
Laboratory Employee’s Signature Initials<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">3 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">After
updated<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Laboratory
Test filled–out Requisition Forms (Clinical Laboratory Request) <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Record
Book<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">After
Date of Last Entry<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">General
Laboratory Test Results<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">General
Patient Registry<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td colspan="5" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l6 level1 lfo12; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Laboratory Test Reports</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Clinical
Laboratory <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Cytogenetics
<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">20 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Cytology<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Drug
Test Reports:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Negative<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 32;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l10 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Positive
with Medico–legal concerns <o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 6cm;" width="227">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanent**<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 33;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Medico–legal
<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 6cm;" width="227">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanent**<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 34;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Surgical
Pathology<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 35;">
<td colspan="5" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l6 level1 lfo12; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Special Laboratory Files</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 36;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Flow
Cytometry Histograms and Dot Plots<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 37;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Electrophoresis
<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1 year<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1 year<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 38;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Cytogenetic
Diagnostic Images (Digitized, Prints or Negatives)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.05pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57.35pt;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">20 years<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 39;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 169.85pt;" valign="top" width="226">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Forensic
Autopsy Gross Photographs or Negatives<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 6cm;" width="227">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanent**<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 110.85pt;" valign="top" width="148">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 40;">
<td colspan="5" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">*Adopted
from the approved Records Disposition Schedule (RDS) by the National Archives
of the Philippines as disseminated through the Department Circular 2021 –
0226 <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 41; mso-yfti-lastrow: yes;">
<td colspan="5" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">**
Permanent records are those with enduring value and classified in the Records
Disposition schedule that have been selected for permanent preservation
(National Archives of the Philippines).<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="2" style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l7 level1 lfo11; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">SLIDES, SMEARS
AND PARAFFIN BLOCKS<o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo16; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Anatomic Pathology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Retention
Period<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Forensic
Autopsy Stained Slides and Paraffin Blocks<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanent<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Surgical
Pathology and Immunohistochemistry Stained Slides and Paraffin Blocks<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Tissue
Frozen Section-Stained Slides and Stained Smears<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo16; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Cytogenetics</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanently
Stained Slides<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">3 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo16; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Cytology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Cytology
Negative / Unsatisfactory Stained Slides<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Cytology
Positive / Suspicious Stained Slides<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Fine
Needle Aspiration Biopsy-Stained Slides<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Gynecologic
Stained Slides<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo16; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Hematology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Bone
Marrow Smears<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Bone
Marrow Tissue Biopsy Slides and Paraffin Blocks<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">10 years<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Malaria
Stained Smears<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1 year<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Other
Body Fluids Slides for Cell Counting <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7 days<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Peripheral
Blood Slides (Abnormal) <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1 year<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Peripheral
Blood Slides (Normal)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7 days<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo16; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Microbiology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">AFB–stained
Smears<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1 year<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Grams
and Trichome Stained Slides<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7 days<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">KOH
Slides <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" width="176">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7 days<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td colspan="2" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l7 level1 lfo11; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">SPECIMENS</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Anatomic Pathology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Body
Fluids for Cytology<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7
days, refrigerated <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Formalin–fixed
representative tissues suitable for DNA Analysis<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanent
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Thin
Prep Aliquot Tubes<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">30
days, Room Temperature<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Wet
and Formalin–fixed tissues for Forensic Autopsy<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
year after completion of final report <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Wet
and Formalin–fixed tissues for Routine Histopathology (Benign) <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2
weeks after completion of final report <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Wet
and Formalin–fixed tissues for Routine Histopathology (Malignant)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">4
weeks after completion of final report<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 32;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Blood Banking and Transfusion Medicine</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 33;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ABO
Blood Typing (EDTA – Whole Blood and Serum)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7
days<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 34;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Crossmatch
Unit Segments from blood donor units and recipients<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7
days post –transfusion <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 35;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Direct
Antiglobulin Test <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7
days <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 36;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Serum
with positive Antibody Screening Test <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
year, Frozen <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 37;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Clinical Chemistry and Immunology / Serology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 38;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Immunofixation
Gels <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
year, Room Temperature<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 39;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Other
Body Fluids (Pleural/Peritoneal/Pericardial Fluid)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
week, Refrigerated <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 40;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Serum/Plasma<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
week, Refrigerated <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 41;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Clinical Microscopy</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 42;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">24–hour
Urine, aliquot<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
day, Refrigerated <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 43;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Drug Testing and Toxicology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 44;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Body
Fluids and Tissues for Toxicology <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">(with
medico–legal concerns)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Permanent
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 45;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Urine
(Negative Screening Test) <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">5
days, Frozen <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 46;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Urine
(Positive Screening Test)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
year, Frozen <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 47;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Hematology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 48;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Anti–coagulated
(Heparinized or EDTA) Whole Blood<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">24
hours, Room Temperature <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 49;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Plasma
for Coagulation Testing<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">24
hours, Room Temperature <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 50;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Microbiology</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 51;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Blood
Cultures<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">7
days inside the machine<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 52;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Culture
Swabs<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
day, Room Temperature<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 53;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Sputum<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
day, Refrigerated<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 54;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Urine
for Culture<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
day, Refrigerated<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 55;">
<td colspan="2" style="background: rgb(46, 116, 181); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: accent5; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l12 level1 lfo17; text-align: center; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Molecular Laboratory</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 56;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Nasal
and Oropharyngeal Swabs (Abnormal)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">30
days, Frozen <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 57;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Nasal
and Oropharyngeal Swabs (Normal)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
day, Frozen<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 58;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Other
Tissue Swabs for viral isolation <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">30
days, Refrigerated<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 59; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 318.7pt;" valign="top" width="425">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Serum
/ Plasma<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 132.1pt;" valign="top" width="176">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1
week, Refrigerated <o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFXVrqWx2SSdww1OPVWVNNxvvJUDvEfy0cZLt2GSyVhc9E5O5AVCLUfw4icUDxEShEVQsW23lNpYiJYuegQQ81di0DyM2EuBSi5quPHrhhEFLOfa__zn1r57nT2yFA_7It8SMoKf06Fm7bdL5JJE7Af5Z7qM5IoQJsQztBQShdrrAFdipar6vPQZXcb14/s165/Microscope2.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" data-original-height="165" data-original-width="159" height="165" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFXVrqWx2SSdww1OPVWVNNxvvJUDvEfy0cZLt2GSyVhc9E5O5AVCLUfw4icUDxEShEVQsW23lNpYiJYuegQQ81di0DyM2EuBSi5quPHrhhEFLOfa__zn1r57nT2yFA_7It8SMoKf06Fm7bdL5JJE7Af5Z7qM5IoQJsQztBQShdrrAFdipar6vPQZXcb14/s1600/Microscope2.jpg" width="159" /></a></div><br />MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-73131129250435753092023-05-24T18:16:00.000+08:002023-05-24T18:16:33.489+08:00ADMINISTRATIVE ORDER No. 2021 – 0059<p><span style="color: #01ffff; font-size: large;"> <span style="font-family: "Palatino Linotype", serif;">03
December 2021</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;"><span style="font-size: x-large;">GUIDELINES ON
ETHICAL ORGAN DONATION AND TRANSPLANTATION FROM LIVING DONORS</span><span style="font-size: large;"><o:p></o:p></span></span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><a href="https://mt-lectures.blogspot.com/2018/06/republic-act-no-7170.html" target="_blank">Republic Act No. 7170</a></span><span style="font-family: "Palatino Linotype", serif;">, as amended,
otherwise known as the “Organ Donation Act of 1991” emphasizes the importance
of pursuing deceased organ donation. Further, this act states that the
“Secretary of Health shall endeavor to persuade all health professionals, both
government and private, to make an appeal for human organ donation.” The
Department of Health (DOH) strongly pushes to end the unethical and illegal
practices on organ donation by unscrupulous individuals, especially among
living non–related donations or from living donors not related by blood to the
recipients. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Organ transplantation when deemed
appropriate has become the preferred option for patients with End Stage Organ
Disease. Administrative Order 2010 – 0018 entitled Revised National Policy on Living
Non–Related Donation and Transplantation and its Implementing Structure
Amending for the Purpose of Administrative Order No. 2008
– 004 – A mandates the National Transplant Ethics Committee (NTEC) to
formulate national ethical standards/guidelines on organ donation and
transplantation for approval by the DOH. Both Living Related and Living
Non–Related donors shall be covered by these ethical guidelines since they are
healthy individuals and the surgical removal of a part or the whole organ is an
invasive procedure that may have later effects on their health and physical,
emotional, and social circumstance. The guidelines shall uphold the protection
and best interests of any Living Donor and Recipient. These shall ensure the
voluntariness of the donation and the protection of the rights, welfare, and
safety of the organ donor.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Order establishes the principles,
policies and guidelines on ethical organ donation and transplantation from
living donors for the reference of health professionals and transplant
facilities performing organ donations and transplantation and other related
health facilities. Additionally, this order seeks to ensure the protection of
the rights, welfare, and safety of the organ donors and recipients. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SCOPE AND COVERAGE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall apply to all government
and private hospitals engaged in organ donation and transplantation, the
National Transplant Ethics Committee (NTEC), Hospital Transplant Ethics
Committee (HTEC), and all others concerned.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This shall also govern the conduct of
practice of all those assigned in organ donation and transplantation from
living donors.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF
TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Attending
Physician </span></b><span style="font-family: "Palatino Linotype", serif;">–
the doctor primarily attending to the recipient and his donor.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Donor
Advocate</span></b><span style="font-family: "Palatino Linotype", serif;">
– a Physician or a collegial body that has no relationship in any way with the
recipient and the donor, who can assess and ascertain the medical and surgical
suitability of the donor for the recipient.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Filipino
Dual Citizen (FDC)</span></b><span style="font-family: "Palatino Linotype", serif;">
– a natural–born Filipino who has become a citizen of another country by reason
of naturalization and who retained or re–acquired his/her Philippine
citizenship or who was granted recognition as a Filipino citizen by virtue of
Republic Act No. 9225, otherwise known as the “Citizenship Retention and
Reacquisition Act of 2003” and its implementing rules and regulation (IRR).
Also, FDC is a foreign national, who has been acknowledge or recognized as a Filipino
citizen, because his father and/or mother was/were Filipino citizen(s) at the
time of the FDCs birth.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Foreigner</span></b><span style="font-family: "Palatino Linotype", serif;"> – a person also
referred to as an alien who does not fall in any of the categories as
enunciated in Section I, Article IV of the 1987 Constitution of the Republic of
the Philippines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Those
who are citizens of the Philippines at the adoption of this Constitution.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Those
whose fathers or mothers are citizens of the Philippines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Those
born before 17 January 1973, of Filipino mothers, who elect Philippine
citizenship upon reaching the age of majority, and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Those
who are naturalized in accordance with the law.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Hospital
Ethics Committee</span></b><span style="font-family: "Palatino Linotype", serif;">
– a group of individuals trained in ethics from different disciplines, age
groups, gender, and professions, established by a hospital or health care
institution, whose main function is to address ethical issues involving patient
care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Hospital
Transplant Ethics Committee</span></b><span style="font-family: "Palatino Linotype", serif;"> – is a trained multi–sectoral committee that
attends to ethical issues surrounding organ transplantation within the
transplant facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Living
Donors</span></b><span style="font-family: "Palatino Linotype", serif;">
– persons of age 21 years of age and above who, and who are mentally competent:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l19 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Living
Related Donors (LRD)</span></b><span style="font-family: "Palatino Linotype", serif;">
– living donors who are related to the recipient by blood within the fourth
degree of consanguinity (e.g., parents, children, siblings, nephews/nieces,
first cousins).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l19 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Living
Non–Related Donors (LNRD)</span></b><span style="font-family: "Palatino Linotype", serif;"> – living donors who are not related to the donors
by blood. Relatives who are beyond the fourth degree of consanguinity are also
considered to be LNRD.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">LNRD are classified as:</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l18 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">“Emotionally
Related” Donors</span></b><span style="font-family: "Palatino Linotype", serif;">
– not related by blood to the recipient but bear close emotional ties with
him/her that are proven beyond question (e.g., spouses, relatives by affinity,
friends, colleagues, fiancé/fiancée and adoptive parents or children, employee
– employer relationships).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l18 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Commercial
Donors (organ vendors)</span></b><span style="font-family: "Palatino Linotype", serif;"> – offer their organs with monetary or other
payments as precondition and prerequisite to the organ donation. Commercial
donors are prohibited.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">LNRD can also be classified as:</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Direct
Organ Donor</span></b><span style="font-family: "Palatino Linotype", serif;">
– a living donor who has a specific recipient in mind to whom he/she would like
to donate. This follows the principle known as donor designation wherein the
donor’s wishes are given due consideration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Non–Directed
Organ Donor</span></b><span style="font-family: "Palatino Linotype", serif;">
– a living donor who does not have a specific recipient in mind but would
donate to anyone in the list of waiting patients for organ transplant. This is
not in conformity with ethical guidelines and protocol on organ donation and is
therefore prohibited.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">National
Transplant Ethics Committee</span></b><span style="font-family: "Palatino Linotype", serif;"> – is a collegial body created internally by the DOH
and is an integral operational component of the PODTP that shall serve as the
national oversight of the HTECs on ethical issues and dilemmas regarding organ
donation and transplantation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Organ</span></b><span style="font-family: "Palatino Linotype", serif;"> –
differentiated and vital part of the human body, formed by different tissues,
that maintains its structure, vascularization, and capacity to develop
physiologic functions with an important level of autonomy (World Health
Organization).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Organ
Donation</span></b><span style="font-family: "Palatino Linotype", serif;">
– an act of liberality, whereby one disposes gratuitously of one’s organ in
favor of another, who accepts it.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">K.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Organ
Sale</span></b><span style="font-family: "Palatino Linotype", serif;">
– an act when a person (the seller) obligates himself/herself to give his/her
organ to another (the buyer) for a monetary price or its equivalent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">L.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Recipient</span></b><span style="font-family: "Palatino Linotype", serif;"> – receiver of
the organ directly from a donor; can also mean the transplant candidate or a
donee. For this AO, recipients include Filipino citizens, Filipino dual citizens,
and foreigners.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">M.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Transplant
Team</span></b><span style="font-family: "Palatino Linotype", serif;">
– group of healthcare providers responsible for the actual retrieval and
transfer of the organ.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l10 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">N.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Vulnerable
Person</span></b><span style="font-family: "Palatino Linotype", serif;">
– any person who is susceptible to undue influence or other factors that may
impair consent to the donation (e.g., elderly, persons with disabilities or
mental health conditions, prisoners, members of the military, and indigenous
peoples; or any person disadvantaged economically, professionally, or socially
directly or indirectly in relation to the recipient). If the donor is a
vulnerable person, extra measures shall be undertaken to guard against
exploitation. These measures include ensuring that:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
donor can comply with all the requirements of an informed consent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
emotional relationship with the donor is established without question. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span class="MsoHyperlink"><span style="font-family: "Palatino Linotype", serif; text-decoration: none;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></span><span style="font-family: "Palatino Linotype", serif;">Organ
donation and transplantation shall be guided by the principles and values which
aspire to manifest fidelity and achieve trustworthiness in organ donation and
transplantation. (See Annex A) </span><a href="https://bit.ly/NTEC-AO"><span style="font-family: "Palatino Linotype", serif;">https://bit.ly/NTEC-AO</span></a></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
National Transplant Ethics Committee shall serve as the national oversight of
the HTEC on ethical issues and dilemmas regarding organ donation and
transplantation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Hospital Transplant Ethics Committee shall be required for the accreditation of
all transplant facilities. An existing Hospital Ethics Committee (HEC) may
perform the functions of the HTEC. It shall abide by the norms and expectations
required for HTEC which may be more than what HEC does in its usual work, processes,
or procedures. There shall be a separate HTEC supported by a secretariat. The
hospital administration shall provide administrative support and the honoraria
of the HTEC members. (See Annex B)</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo8; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">National
Transplant Ethics Committee (NTEC)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l20 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NTEC shall be composed of a Chairperson, Co–chairperson, and seven (7) Cluster
Expert Members to be designated by the Secretary of Health from representatives
of the hospitals, academe, socio–civic organisations, government organizations
and religious organizations and who shall serve for a term of 3 years. The
members shall continue to serve on a holdover capacity at the end of their
terms until such a time a replacement has been appointed. A Department
Personnel Order (DPO) shall be issued for this purpose.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l20 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NTEC shall report to the Secretary of Health</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l20 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Philippine Network for Organ Sharing (PhilNOS) under Philippine Organ Donation
and Transplantation Program (PODTP) shall serve as the secretariat of the NTEC
as mandated by DPO No. 2018 – 4821 “Reconstitution of the National Transplant
Ethics Committee (NTEC) under the Department of Health” and its amendments DPO
No. 2018 – 4821 – A and 2018 – 4821 – B.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l20 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
operating expenses for the NTEC shall come from the Department of Health
Disease Prevention and Control Bureau in accordance with DPO 2018 – 4821 – B.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Organ
Donors</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
potential donor shall be 21 years old or above who voluntarily offers his/her
organ. The potential donor must be ascertained to be an appropriate donor in accordance
with standard medical practice and with the principles and provisions of this
Order (see Annex D). He/she should be related to the recipient up to the 4<sup>th</sup>
degree of consanguinity or at least have established emotional ties with the
recipient. (See Annexes C.1 and C.2)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Potential
LRDs shall be given priority over LNRDs. A document indicating the reason for
the selection of the donor shall be submitted by the attending Physician of the
recipient. If a recipient has several donors who do not have any distinct
physical or compatibility advantage, the donor who is more emotionally and
psychologically mature shall be selected. This shall be determined by the donor
advocate or a person with the same qualifications designated by the transplant
facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
potential donor and his/her spouse or if not married, a member of his/her
family shall attend a Pre–Transplant Orientation in any DOH licensed and
PhilHealth accredited transplant hospital. The orientation shall include among
others an overview of the organ donation and transplantation procedure,
importance of informed consent, benefits and risks to the donor and recipient,
recognition and management of adverse effects, policies and guidelines related
to the procedures, responsibilities of donors, recipients, transplant team and
hospital, long term follow up requirements, previous outcomes, and alternatives
to transplantation. A certificate of attendance shall be included in the
evaluation of the donor by the HTEC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
transplant facility/institution shall designate a donor advocate for the
potential donor.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
the potential donor passes the initial matching tests, he/she shall be
evaluated by a Psychiatrists or Clinical Pyschologist for competence in
decision–making, motive for the donation, coercion or any limitation to free
choice, and clarification of personal values. The Psychiatrist/Psychologist
shall ensure that the donor is able to give free and informed consent. A
corresponding report of this evaluation shall be submitted to the HTEC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
potential donor shall be evaluated by a social worker to check the
socio-economic status and for any financial inducement. The social worker shall
make a home visit to ascertain the motivation for the donation, real living
conditions, family situation and actual address of the donor. The written
report of the social worker shall be included in the HTEC deliberation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
eventual outcome of the evaluation and the decision to pursue or not to pursue
the match and the basis for the decision shall be communicated to the
transplant coordinator, attending Physician and to the potential donor. (See
Annexes D, D.1)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
approved as a potential donor, informed consent shall be obtained by the
Surgeon. His/her spouse or if not married, a member of his/her family shall
again be given the same information as during the orientation. The patient
shall be given time to reflect, discuss and ask questions. If he/she chooses to
donate, consent forms and a Deed of Donation as required by the IRR of R.A. 9208 written in a dialect/language that is
understandable to the donor are signed and witnessed. The informed consent
process shall be documented and witnessed by persons unrelated to either the
donor or the recipient and is not a member of the transplant team of the
recipient. At any time before the donation, the potential donor is made to
understand that he/she is free to change his/her mind and may withdraw his/her
offer to donate. It shall also be made clear to the donor that he/she will not
be charged for any procedure related to the donation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HTEC shall be provided with all the pertinent documentation during the time of
their interview with the potential donor. The HTEC shall evaluate, then approve
or disapprove the proposed donation based on this Administrative Order. The
HTEC Certificate of Approval/Disapproval shall be given and included in the
donor’s and recipient's charts. A total of seven copies shall be made and a
copy be given to the donor, recipient, attending Physician, Transplant Surgeon,
Transplant Coordinator, National Registry and HTEC. Additional copies may be
submitted to fulfil other administrative requirements. (See Annex D, D.1 and E)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
donor shall be admitted and given the appropriate pre–operative, peri–operative
and post–operative hospital care including treatment of any post–operative
complications.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Upon
discharge, the attending physician shall again explain to the donor and his/her
spouse or a close relative or social relationship if not married, what was
done, risks present, the importance of lifestyle conditions and follow up
monitoring as required by good clinical practice. The follow up of the donor
may be done by his/her attending Physician. He/she may also be referred to
his/her original Physician for further follow up once the patient is completely
stable. The HTEC shall ensure that there is a monitoring system within the
institution that the donor is being followed up over his/her lifetime. Donor
follow–up shall be done according to the DOH guidelines on donor monitoring.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">12.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">All
medical expenses related to the donation including donor care and follow up
shall not be charged to the donor by the transplant facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">13.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Consistent
with provisions of the R.A. 10173 or the Data Privacy Act of 2012, all personal
information regarding the organ donor shall be kept confidential except when
regulatory authorities request information regarding the donation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Organ
Recipient</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
transplant candidate bearing a certificate form his/her attending Physician of
the patient’s need and suitability for an organ transplant shall be submitted
to the registry of recipients that is to be found in the Philippine Organ Donor
and Recipient Registry (PODRRS).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
an enrolled PODDRRS, he/she shall be eligible to receive an organ from a
deceased donor following the guidelines for organ allocation from deceased
donors (<a href="https://mt-lectures.blogspot.com/2018/07/administrative-order-2010-0019.html" target="_blank">A.O. 2010 – 0019</a> and A.O. 2010 – 0019 – A).
However, if a Living Donor is willing and available, the recipient can opt for
this instead and shall inform PhilNOS of their availment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
potential recipient and his/her spouse or if not married, a member of his/her
family shall attend a Pre–Transplant Seminar Orientation in any DOH licensed
and PhilHealth accredited transplant hospital. The seminar shall include among
others an overview of the organ donation and transplantation procedure,
importance of informed consent, benefits and risks to the donor and recipient, recognition
and management of adverse effects, policies and guidelines related to the
procedures, responsibilities of donors, recipients, transplant team and
hospital, long term follow–up requirements, previous outcomes, and alternatives
to transplantation. A certificate of attendance shall be provided to the HTEC
during the evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Records
of the recipient shall be submitted to the HTEC along with other relevant
documents for evaluation and approval or disapproval of the proposed donation
based on this Order and the implementing guidelines of the Administrative Order
on Living Donation (DOH A.O. 2010 – 0018). The
HTEC Certificate of Approval shall be given to the recipient and to the
national registry.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
recipient shall be admitted for the transplant and shall be given the
appropriate pre–, peri–, and post–operative hospital care including treatment
of any post–operative complications.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Upon
discharge, the attending Physician shall again explain what was done, risks
present and the importance of follow–up care. He/she shall also refer the
recipient back to his/her original Physician.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
attending Physician shall submit to the HTEC an abstract of the patient's
records as well as the name of his/her assigned attending Physician.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l12 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Consistent
with the provisions of the R.A. 10173 or the Data Privacy Act of 2012, all
personal information shall be kept confidential except when regulatory
authorities request information regarding the transplantation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Foreign
Organ Donors and Recipients</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Foreigners
shall be eligible to receive professional medical care including organ
transplantation in the Philippines. However, foreign patients cannot receive
organs from living non–related Filipino donors as stipulated in the R.A. 9208,
otherwise known as the Anti– Trafficking in Persons Act of 2003.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
foreign patients, the organ donor shall be a:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Related
donor–up to 4<sup>th</sup> degree of consanguinity (parents, siblings,
children, and first cousins of the recipient).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l23 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Spousal
donor – at least (3) years legally married.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
addition, the following guidelines shall apply to foreign recipients and
foreign related donors to ensure that human trafficking for organ donation does
not occur.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
patient and/or patient’s doctor shall communicate with a Philippine hospital
and accredited transplant surgeon regarding medical status of recipient and
donor. The hospital or Surgeon shall inform them of the Philippine
requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Before
going to the Philippines, the patient and donor shall be evaluated by a
hospital ethics committee in their country.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Required
documents to be submitted of the HTEC before surgery shall be authenticated by
the Consular Office/Embassy of the appropriate Ministry of foreign country and
should have an accompanying English translation. (See Annex C.2)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
addition to the requirements, the transplant candidate and donor upon coming to
the Philippines shall be interviewed separately by the HTEC of the hospital
where surgery will be performed. This interview shall be documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Based
on the guidelines, the HTEC shall decide whether to approve or disapprove the
case. If disapproved, the reasons shall be clearly stated and documented. (See
Annex D, D.1 and E)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
HTEC approves the donation, it shall inform NTEC of the case within 24 working
hours. The NTEC has the right to review and overrule the decision of the HTEC
within 24 working hours from receipt of HTEC information. If NTEC does not
respond within the time, it is presumed that the case has been approved and the
transplant facility shall proceed with the surgery.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HTEC shall consult with NTEC in cases where the HTEC has questions or
unresolved issues related to this matter.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
NTEC shall conduct an audit of the HTEC about organ transplantation and
donation cases involving foreign recipients and donors as deemed necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HTEC shall include required documents (together with the interview
documentation) of foreign patients and donors when it submits its quarterly
report to the NTEC.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l17 level1 lfo13; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">ROLES
AND RESPONSIBILITIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l2 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Department
of Health – Central Office shall develop systems, policies and guidelines that
will facilitate the implementation of organ donation and transplantation form
living donors at all levels. As such, the following offices shall have the
following responsibilities:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">National
Transplant Ethics Committee shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Formulate
the national ethical standards and guidelines on organ donation and
transplantation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist
in the development of legislation, rules and regulations regarding organ
donation and transplantation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
opinions, recommendations and final resolution of cases referred by HTECs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Foster
awareness on organ donation and transplantation ethical healthcare issues.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Participate
in international discussions through interactions and collaboration with
similar committees and organizations working in this field.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
technical assistance and monitor HTECs in the performance of their functions,
helps in the accreditation of the transplant facility by the HFSRB by assessing
the HTECs of the transplant facility to ensure compliance with ethical
standards and guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l13 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Perform
other functions assigned by the Secretary of Health.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Public
Health Services Team (PHST) through</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Philippine Organ Donation and Transplantation Program (PODTP) shall:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l22 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Oversee
the organ donation and transplantation system in the country.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l22 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitor
compliance of the transplant facilities to policies set forth by this order and
other operational guidelines that may be formulated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l22 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Perform
other functions assigned by the Secretary of Health related to its primary
function.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Philippine
Network for Organ Sharing (PhilNOS) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l21 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Act
as the central coordinating body to ensure that all donor kidneys/organ from
deceased donors are allocated according to established criteria.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l21 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain
the Philippine Organ Donor and Recipient Registry System (PODRRS).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108.0pt; mso-list: l21 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Shall
serve as the Secretariat of the NTEC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Health
Facility Development Bureau (HFDB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l15 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
technical assistance to transplant facilities in alignment with the Philippine
Health Facility Development Plan (PHFDP) 2020 – 2040.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l15 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
the alignment to the requirements (human resource for health, equipment, and
infrastructure) in organ donation and transplantation guidelines with Resource
Stratified Framework for renal care and transplant.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Health
Facilities and Services Regulatory Bureau (HFSRB) shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l5 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure
compliance of Accredited Kidney Transplant Unit’s HTEC to the guidelines of the
NTEC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l5 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Impose
sanctions and penalties for ethical violations recommended by the NTEC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l2 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
Transplant Hospitals shall establish a Hospital Transplant Ethics Committee in
their respective hospitals and shall comply with the rules and regulations
governing their accreditation and operation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l2 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HTEC shall fulfil the requirements for national and international assurances as
it functions in accordance with the national laws and relevant rules and
regulations. (Annex B)</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l2 level1 lfo16; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">VIOLATIONS
AND SANCTIONS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l8 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Non–compliance
of the transplant facilities with the standards and policies of this
Administrative Order shall be investigated and sanctioned by the DOH in
accordance with the existing relevant issuances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l8 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Furthermore,
any violations by erring professionals shall be forwarded to the DOH and to the
Professional Regulatory Commission (PRC), as applicable, for appropriate
sanctions. The referral of the said violations to the DOH and PRC shall be
without prejudice to the filling of appropriate civil or criminal charges
whenever warranted.</span></span></p><p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l8 level1 lfo24; text-indent: -18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The provisions in this Order shall
supersede any sections in existing provisions or administrative issuances that
are not consistent with the contents of this order. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">X.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SEPARABILITY
CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">If any provision or part of this Order
be declared unauthorized or rendered invalid by any court of law of competent
authority, those provisions not affected by such declaration shall remain valid
and effective.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">XI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall take effect fifteen
(15) days following its publication in the Official Gazette or a newspaper of
general circulation and upon filing with the University of the Philippines Law
Center of three (3) certified copies of this Order.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO
T. DUQUE III, MD, MSc<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary
of Health</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-13338655790099092092023-05-24T17:44:00.000+08:002023-05-24T17:44:31.772+08:00Administrative Order No. 2018 – 0025<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></b></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;"><span style="font-size: x-large;">NATIONAL POLICY
AND STRATEGIC FRAMEWORK ON EXPANDED NEWBORN SCREENING FOR 2017 – 2030</span><span style="font-size: large;"><o:p></o:p></span></span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">BACKGROUND</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">For two decades, the Newborn Screening
(NBS) Program has successfully laid its foundation by integrating the program
to the existing health system and infrastructure as outlines in the NBS
strategic framework. Workshops for strategic planning on NBS were conducted in
2001 and 2009, respectively. Initially, the focus was on building the
foundation for the NBS program and how it will be implemented in major
facilities. Later, the program aimed to increase the national coverage by
continuous implementation of NBS to the rest of the facilities nationwide and
integration to the service delivery network through policies and advocacies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Today, the National Comprehensive
Newborn Screening System (NCNBSS) thrust in the next thirteen years is to
ensure the sustainability of (NCNBSS), including the full shift to expanded
newborn screening and the provision of continuing care for confirmed patients
for any of the screened disorders. Several policies were released in 2014 in
pursuit of these thrusts such as <a href="https://mt-lectures.blogspot.com/search?q=Administrative+Order+No.+2014+%E2%80%93+0045" target="_blank">Administrative OrderNo. 2014 – 0045</a>, which set the guidelines on the implementation of the
Expanded Newborn Screening (ENBS) program and provided the option for parents
to avail between the 6–test and ENBS test; and the DOH Administrative
Order 2014 – 0035 that facilitated the initial establishment of the NBS
Continuity Clinics in 14 regions to facilitate continuity of care of confirmed
patients in their area of coverage.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Department of Health (DOH) in
coordination with its program partners reconfigured the NCNBSS framework for
2017 – 2030 to provide direction and to intensify the implementation,
especially the ENBS. The plan shall concretize the long–term goals of NCNBSS.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order aims to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
a strategic framework for the implementation of the Expanded Newborn Screening
Program from 2017 – 2030; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l7 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
policy direction and guidance for DOH offices, its attached agencies, LGUs, and
development partners in prioritizing interventions for the health of newborns. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">COVERAGE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Order shall apply to the entire public
and private health system, including DOH bureaus, Regional Offices (ROs),
hospitals and other health facilities, attached agencies, local government
facilities, external development partners and other stakeholders implementing
health programs for and with pregnant women, mothers, and newborns. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF
TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening</span></b><span style="font-family: "Palatino Linotype", serif;">
is an essential public health strategy that enables the early detection and
management of several congenital disorders (metabolic and endocrine disorders,
hemoglobinopathies, and cystic fibrosis), which if left untreated, may lead to
mental retardation, disability and/or death.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Long
term management system</span></b><span style="font-family: "Palatino Linotype", serif;"> is the provision of appropriate management,
intervention, and support services to all confirmed cases of NBS disorders to
enable optimal, physical, mental, and social outcomes for these individuals.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l13 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
National Policy and Strategic Framework on Expanded Newborn Screening for 2017
– 2030 shall guide healthcare interventions on newborn screening to be able to
attain the following targets by 2030:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">At
least 95% national coverage of the expanded newborn screening.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">At
least 90% of health facilities with maternity and newborn services that
includes expanded newborn screening.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">At
least 95% monitoring data are generated from regional offices and Newborn
Screening Facilities (NSFs) through online monitoring system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">100%
ISO certification of all newborn screening centers and newborn screening
reference center;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> 1</span></span></span><span style="font-family: "Palatino Linotype", serif;">00%
of comprehensively trained and certified personnel who will perform NBS
collection in NSFs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">At
least 95% of regions maintained 99% satisfactory sample collection rate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">100%
PHIC coverage of the newborn care package to include ENBS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l5 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">At
least 85% of identified strategically located provinces with established
long–term management system for NBS confirmed positive patients. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l13 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">STRATEGIC
FRAMEWORK</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The Newborn Screening Program is guided
by the following principles: (a) integration with all child health programs;
(b) evidence–based interventions/approach, quality; and (c) sustainability and
partnership and shared responsibilities. The Strategic Framework for Newborn
Screening directs the program for the next 13 years and is aimed to ensure the
sustainability and nationwide implementation of expanded newborn screening program
through actionable program components and variety of strategies (See Annex A).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The shift from the six–panel screening
into an expanded screening for 28+ panel of heritable disorders would entail
upgrading, strengthening, and sustaining the different program components with
the result of delivery of quality of services through ISO certified facilities
and reaching out to every infant in the community. The service is not limited
to screening alone but long–term management of children who are confirmed
positive for congenital disorders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l13 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
targets are to be achieved through the following strategies:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">STRATEGIES</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Ensuring
Efficient Operations, Systems, and Network Management</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This shall be upgraded to reach areas
that need access to newborn care. This includes construction and/or renovation
of well–planned and equipped infrastructures to ensure quality service among
patients and to engage more health facilities to offer NBS services (human
resource for health–trained and capacitated).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Development
of Manual of Operation and Standards from screening, confirmatory testing to
referral and management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">ISO
15189:2012 Certification of all Newborn Screening Centers (NSCs).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l9 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Information
dissemination geared towards importance and regulation of testing in
confirmatory centers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Expanding
Package of Services and Delivery Network</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In the next ten years, the program aims
to shift fully into expanded newborn screening. Enrolment of new facilities and
sustaining the operations of existing facilities is critical in increasing the
coverage of service delivery. Strategic actions to increase the uptake of ENBS
are critical to ensure nationwide implementation, which involves strong
promotion, advocacy, and cooperation of the newborn screening facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Opening
of additional three NSCs shall ensure expedient sending and receiving of
results to and form geographically isolated and disadvantaged facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Setting
up continuity clinics and referral system in the provinces to further
strengthen the referral and management network of positive cases in the hope
that no patient will be deprived of long–term care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Strict
enforcement of newborn screening policies to ensure delivery of sustainable
ENBS service at the national level down to local level.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Enhancement
of diagnosis, follow up, and management of confirmed cases through prompt
recall and confirmatory tests of patients by effective utilization of patients,
collaborative partnerships and assessment of recall and follow-up protocols.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Training
and deployment of clinical geneticists, pediatric endocrinologist, and genetic
counsellors at the provincial level.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l6 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop
human resource complement positions at the DOH and Local Government Units
(LGUs) to ensure that nurses, doctors, and other health professionals working
in the continuity clinics and regional offices are given plantilla positions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Enhancing
Health Promotion and Advocacy</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This requires a developed and
well–coordinated comprehensive health promotion and communication plan
targeting different audiences to increase awareness and uptake on expanded
newborn screening. It shall also focus on information campaign by strengthening
communication strategies using different medial platforms.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop
an ENBS national communications plan to increase the uptake of ENBS nationwide.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Strengthen
alliance building with different organizations and Local Government Units
(LGUs).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Integrate
ENBS in the academic curriculum with other health related subjects in the
secondary and tertiary levels, specifically in Grade 8 level.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l0 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Intensify
training and development of innovative training materials for newborn screening
with post training evaluations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Optimizing
Health Information Management Systems for Expanded Newborn Screening</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This aims to optimize current
investments on health management information systems by adopting interoperable,
consensus–based, evidence–driven and standards–based vocabularies and system
that maximize the use of electronic health record systems that will
automatically process and send information and reports to (a) Philhealth for
verification of claims for NBS, and (b) the NBS registry for program planning
and research purposes, among others.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish
efficient national database and case registries for real–time generation of
data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l11 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop
and implement online monitoring system for easy access of data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(5)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Strengthen
Monitoring and Evaluation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Program monitoring and evaluation of
procedures and systems, both for laboratory and administrative units shall be
undertaken to ensure smooth implementation of the program. Periodic review of
monitoring and evaluation tools should be done including quality assurance
assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Modify
NBS evaluation tools such as the Philippine Performance Evaluation Assessment
System (PPEAS) tools for NSCs, ROs, Continuity Clinics and NSFs for periodic
assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct
program review, audit and evaluation procedures and systems for both laboratory
and administrative units.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l4 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish
local QA laboratory for the monitoring and evaluation of Newborn Screening
Centers (NSCs).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(6)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Establishing
Sustainable Financing Scheme</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The DOH, as the lead agency of the NBS
program shall allocate funds for the set–up of new strategically–located
newborn screening centers. The National Comprehensive Newborn Screening System
(NCNBSS) also ensures funding for research relevant to the implementation of
newborn screening at the national level that maybe utilized for policy
recommendations. The Philippine Health Insurance Corporation (PHIC) also
ensures full coverage of expanded newborn screening, while LGUs and other
stakeholders and partners are empowered to provide ways or means to make the
NBS accessible and affordable, particularly on the economically depressed
areas.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l3 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Include
full coverage of ENBS in the PhilHealth nerwborn care package.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l3 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
funds for research grants for policy recommendations on NBS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l3 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Building
alliance with LGUs and other institutions/agencies to allot budget for
screening, confirmatory tests, and management in the continuity clinics by
having a community financing schemes and programs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt; mso-list: l3 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Continuous
collaboration to include NBS program in the Department of Health investment
plan and allot budget for the needs of newborn screening from the national fund
including health promotion and communication campaign at all levels using
different media platforms. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90.0pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Implementing
Mechanisms</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The DOH Central office shall act as the
lead agency, along with the LGUs, for the implementation of this Order. The
Advisory Committee on Newborn Screening (ACNBS) is the inter–agency body that
reviews and recommends policies and standards to the Secretary of Health. The
DOH created a Technical Working Group on Expanded Newborn Screening whose
primary role is to oversee the implementation of the Program and monitor
progress based on the M&E Framework. (see Annex B)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The following summarizes the roles and
functions of the different group of stakeholders that have critical roles in
the Newborn Screening Framework 2017 – 2030:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">DOH
– Disease Prevention and Control Bureau</span></b><span style="font-family: "Palatino Linotype", serif;"> shall undertake the following tasks:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Disseminate the strategic
framework and enabling policies to ensure implementation of the strategies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Mobilize funds and various
resources of various offices and agencies for the set–up of strategically
located new newborn screening centers, confirmatory centers, and continuity
clinics all over the country.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide human resource complement
through the provision of plantilla positions for nurses, doctors, and other
health professionals to assure availability of dedicated and committed staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide technical and
inputs/assistance in developing a health promotion and communication plan &
materials for ENBS in collaboration with HPCS and NIH – NSRC to educate health
professionals and the public.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Oversee the conduct of regular
monitoring and evaluation of the program implementation.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
– Health Facilities and Services Regulatory Bureay (HFSRB)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Include certification from NSRC
as part of licensing requirements for hospitals and birthing facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Include NBS in their monitoring
compliance in giving license to operate to hospitals and birthing facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
– Health Human Resource Development Bureau (HHRDB)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Provision of human resource complement
through the provision of plantilla positions for nurses, doctors, and other
health professionals to assure availability of dedicated and committed staff is
beyond the DOH capacity.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop competency–based modules
on NBS for health service providers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Man potential partner
institutions to deliver NBS courses per region and per province.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitor the learning and
development of NBS providers in coordination with the Regional Office Program Coordinators
and Training Specialists.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
– Health Promotion and Communication Service (HPCS)</span></b><span style="font-family: "Palatino Linotype", serif;"> shall develop
comprehensive Newborn Screening health promotion and communications plan
including prototype information, education & communication (IEC) materials
and collaterals in coordination with DPCB – FHO and NIH – NSRC to facilitate
advocacy for expanded newborn screening.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
– Knowledge Management Information Technology Service (KMITS)</span></b><span style="font-family: "Palatino Linotype", serif;"> shall provide
technical assistance in the (a) development, integration and maintenance of
interoperable, consensus–based, evidence –driven and standards–based
vocabularies and system module on NBS in electronic health record system; (b)
development and maintenance of an NBS registry; and (c) facilitate and ensure
interoperability of these HER systems with the NBS registry and other relevant
information systems to facilitate knowledge management and timely
decision-making.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DOH
Regional Offices and DOH ARMM</span></b><span style="font-family: "Palatino Linotype", serif;"> are the implementing arm of the
Department of Health in the regional level and ARMM, where each has a
designated Newborn Screening (NBS) Coordinator to facilitate and collaborate
the full implementation of the program by the participating health units at the
local level. The coordinators should be responsible of the following tasks:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Disseminate the strategic plan
and enabling policies to LGUs and agencies in the regions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Lead in the conduct of
comprehensive training and orientations to hospitals, health organizations and
the community.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist in all health information
and advocacy activities, particularly in the promotion of ENBS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitor and assist the recall of
patients for immediate tracking and retrieval of positive screening for
confirmatory testing, referral, and proper management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Department
of Interior and Local Government (DILG) in Regional Offices and ARMM</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Encourage LGUs to implement R.A.
9288 and extend total cooperation in the implementation of the said law.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist DOH in the monitoring and
evaluation of the program implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Local
Government Units (LGUs) of regions and ARMM</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop the capabilities of
health workers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Issue local ordinances and
resolutions that integrate NBS in the delivery of health delivery system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure that adequate and
sustained NBS services such as information, education, communication,
screening, recall and follow–up are being provided in all LGU health facilities
(Rural Health Unit/City Health Unit, Lying–Ins, City/Municipal/District/Provincial
Hospitals).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish a functional case
management referral system with strategically accessible NCNBSS treatment
network.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish coordination and
networking among concerned agencies in NBS implementation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Monitor and evaluate the newborn
screening implementation in their localities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Explore/encourage creative
financially packages to make NBS accessible particularly among the poor
populace.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Perform other roles and
responsibilities as deemed necessary for the implementation of this Act.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Philippine
Health Insurance Corporation (PhilHealth)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Include proof of newborn
screening services in their checklist for the accreditation of health
facilities for quality newborn and pediatric services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Facilitate increase of benefit
package for newborns, covering the expanded newborn screening services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Department
of Education (DepEd) and Commission on Higher Education (CHED)</span></b><span style="font-family: "Palatino Linotype", serif;"> shall assist
the DOH on the integration of newborn screening policy in the curriculum to be
implemented by the school and higher education institutions at basic,
secondary, and tertiary levels.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Reference Center (NSRC)</span></b><span style="font-family: "Palatino Linotype", serif;"> is the central facility that provides
technical assistance to the Department of Health. It shall do the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide technical assistance in
setting up NSCs including and capability building.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Define testing and follow–up
protocols.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain an External Laboratory
Proficiency Testing Program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Advocate and disseminate
importance of taking confirmatory tests through creation and distribution of
IEC materials.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Allocate funds for the
fellowships to ensure the availability of qualified health personnel (e.g.,
Clinical Geneticists and Pediatric Endocrinologists) who could be tapped by the
NCNBSS in the follow up treatment and monitoring for prompt and proper
management of newborn babies screened positive.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Develop IEC materials and
training modules among others, for dissemination to partners and facilities,
for ENBS promotions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Oversee the national testing
database, case registries and content of educational materials.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Create a plan for long–term
outcome evaluation of NBS utilizing the case registries.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct regular monitoring and
evaluation of the program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Assist in the national training
activities of the program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Process the transfer of funds to
the regional offices.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">l.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Centers are the facilities equipped with a newborn screening
laboratory that comply with the standards established by the National
Institutes of Health (NIH) and are responsible to the following tasks:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Create capability building plan
and activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide financial support to
continuity clinics.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct all required tests for
all newborn screening samples received.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate immediate recall or short
term follow up of newborns with heritable conditions to sending NSFs and DOH
Ros and DOH ARMM.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Participate in the follow up
programs of newborns screening.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">m.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Host Facility lodged in health facilities shall provide for the venue
or space for newborn screening centers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l8 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">n.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><span style="font-family: "Palatino Linotype", serif;">Newborn
Screening Facility implements the NCNBSS at the community level, which are
responsible for the following tasks:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Integrate NBS in its delivery of
health services specifically maternal and newborn services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Serve as collecting health
facility for NBS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Coordinate with the duly
accredited NSC covering their area.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Ensure that adequate and
sustained NBS services such as information, education, communication,
screening, recall and management of identified cases are being provided in the
hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish a NBS Team that will be
responsible for the following: collection of samples, sending of samples to
accredited NSC, prompt recall of positive patients, referral and management of
patients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Establish an appropriate
financial system that will ensure effective and efficient collection of fees
and payment of NBS services to the NSC.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Conduct orientation and/or
training of hospital staff on NBS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 74.7pt; mso-list: l1 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Define creative financial
packages to make NBS accessible particularly among the poor populace. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The provisions of previous Orders and
other related issuances inconsistent or contrary with the provisions of this
Administrative Order, including A.O. No. 2014 – 0045 are </span><span style="color: #fcff01; font-size: large;">hereby revised, modified, repealed or rescinded</span><span style="color: #01ffff; font-size: large;"> accordingly.
All other provisions existing issuances which are not affected by this Order
shall remain valid and in effect. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SEPARABILITY
CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">If any provision of this Order is
declared unauthorized or rendered invalid by any court of law or competent
authority, those provisions not affected thereby shall remain valid and
effective. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l2 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This Order shall take effect
immediately.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO
T. DUQUE III, MD, MSc<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary
of Health</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX A:
STRATEGIC FRAMEWORK</span></span></b></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td rowspan="2" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 70.65pt;" width="94">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Overall
Mission<o:p></o:p></span></span></p>
</td>
<td colspan="5" style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 380.15pt;" valign="top" width="507">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
National Comprehensive Newborn Screening System shares the vision of the
Child 2025 Planning Framework aiming every Filipino child will be (1) Born
healthy and well, with an inherent right to life, endowed with human dignity
and (2) reaching her/his full potential with the right opportunities and
accessible resources. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 380.15pt;" valign="top" width="507">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To
ensure that all Filipino children will have access to and avail of total
quality care for the optimal growth and development of their full potential. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 70.65pt;" width="94">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Overall Goal<o:p></o:p></span></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 380.15pt;" valign="top" width="507">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To
reduce preventable deaths of all Filipino newborns due to more common and
rare congenital disorders through timely screening and proper management. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 70.65pt;" width="94">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Program
Objectives<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 74.0pt;" width="99">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">By 2030, all
Filipino newborns are screened<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.95pt;" width="179">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Strengthen
quality of service and intensify monitoring and evaluation of NBS
implementation<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 81.75pt;" width="109">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Sustainable
financial scheme<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.45pt;" width="121">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Strengthen
patient management<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 70.65pt;" width="94">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Targets<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 74.0pt;" width="99">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">95% Newborn
Screening Coverage<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.95pt;" width="179">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">95% Monitoring
data are generated from Regional Offices and NSFs through online monitoring
system<o:p></o:p></span></span></p>
</td>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 81.75pt;" width="109">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">100% PHIC
coverage for ENBS<o:p></o:p></span></span></p>
</td>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.45pt;" width="121">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">85% of
identified strategically located provinces with established long term
management system for confirmed positive patients.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 44.2pt; mso-yfti-irow: 5;">
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 74.0pt;" width="99">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">90% of health
facilities with maternity and newborn services that includes expanded newborn
screening<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.95pt;" width="179">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">100% ISO
Certification NSCs and NSRC<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 44.2pt; mso-yfti-irow: 6;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.95pt;" width="179">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">95% of ROs
maintained<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">99% satisfactory
sample collection rate<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 44.2pt; mso-yfti-irow: 7;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.95pt;" width="179">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">100%
comprehensively trained and certified personnel doing NBS collection in NSFs<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 44.2pt; mso-yfti-irow: 8;">
<td style="border-top: none; border: solid windowtext 1.0pt; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 70.65pt;" width="94">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Guiding
principles<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 74.0pt;" width="99">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Integration in
all child health services<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.95pt;" width="179">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Evidence–based
interventions/approach<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 81.75pt;" width="109">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Quality and sustainability
of the program<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.45pt;" width="121">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Partnership
and shared responsibilities among agencies<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 44.2pt; mso-yfti-irow: 9;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 70.65pt;" width="94">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Strategies<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 74.0pt;" width="99">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Ensuring
efficient operations, systems, and networks management<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 133.95pt;" width="179">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Expanding
package of services and delivery network<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 81.75pt;" width="109">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Enhancing
health promotion and advocacy<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 44.2pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.45pt;" width="121">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Optimizing
Health Information Management Systems for Expanded Newborn Screening<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10; mso-yfti-lastrow: yes;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 184.55pt;" width="246">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Strengthen
Monitoring and Evaluation<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 195.6pt;" width="261">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Establishing
Sustainable Financing Scheme<o:p></o:p></span></span></p>
</td>
</tr>
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<td style="border: none;" width="26"></td>
<td style="border: none;" width="110"></td>
<td style="border: none;" width="122"></td>
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</tbody></table></div>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-25240986681339466212023-05-08T21:26:00.000+08:002023-05-08T21:26:44.970+08:00Department Order No. 2020 - 0820<p><span style="color: #01ffff; font-size: large;"> <span style="font-family: "Palatino Linotype", serif;">28 December 2020</span></span></p><p><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">INSTITIONALIZING AND STRENGTHENING THE NATIONAL
REFERENCE LABORATORIES IN THE PHILIPPINES<o:p></o:p></span></span></b></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">National Reference Laboratories (NRLs) were established through <a href="https://mt-lectures.blogspot.com/2017/08/department-order-no-393-e-s-2000.html" target="_blank">Department Order No. 393–E</a> s. 2000, otherwise<span style="mso-spacerun: yes;"> </span>known as the “Designation of National Reference
Laboratories and Transfer of Corresponding Equipment, Instruments, Specimens,
and Records from the Bureau of Research and Laboratories to the Designated
National Reference Laboratories,” to improve the quality of health services and
establish an effective public health laboratory network in the country in line
with the Service Delivery Network pillar of FOURmula 1 Plus towards the attainment
of Universal Health Care goals. The Technical Working Group (TWG) pursuant to
Department Order No. 62–F s. 2002 evaluated the NRLs based on the service
capability and readiness of the host’s hospital. The six (6) hospitals designated
as NRLs are the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">East Avenue Medical Center (EAMC) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Lung Center of the Philippines (LCP)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Kidney and Transplant Institute (NKTI) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Philippine Heart Center (PHC) – designated through DPO No. 2009 – 5148 <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Research Institute for Tropical Medicine <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l6 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">San Lazaro Hospital (SLH)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><a href="https://mt-lectures.blogspot.com/2017/08/administrative-order-no-2012-0021.html" target="_blank">Administrative Order No. 0021</a></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> s. 2012, otherwise known as the “National Framework of the National
Health Laboratory Network,” provides the framework for the organization of all
government and private laboratories at all levels into a functional National Health
Laboratory Network (NHLN), to define the road map and direction for
strengthening and promoting the institutional and operational capabilities of
the health laboratories. The NRL is recognized to provide technical leadership
in the related field and is the highest-level laboratory amongst various
laboratory levels in the Philippines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order aims to strengthen the NRLs to better respond to various
needs of the health sector especially during outbreaks and pandemics.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">OBJECTIVES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l17 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">General Objective:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">To provide an update policy and mandate for the existing six (6) designated
host hospitals with the NRL, through institutionalization of their operation,
and its structural and functional distinction from the host hospital’s
main/central laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l17 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Specific Objectives:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">To provide an enabling mechanism for the institutionalization and
operations of the NRLs, including the budget, manpower complement, and
mechanisms for sustainability.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">To institutionalize and harmonize enabling mechanisms in the operations
of the NRL, thereby providing improved services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l10 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">To strengthen the capacity and capability of NRLs through networking, partnership,
and collaboration with other international reference laboratories in line with
the Universal Health Care for the Filipinos and for the NHLN to be at par with
counterpart national reference laboratories in the ASEAN region, and with
international standards for laboratory methods and technology and to provide
critical inputs as guide to Department of Health (DOH) policies and stakeholder’s
response activities. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SCOPE AND COVERAGE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall apply to the six (6) host hospitals with their designated
NRLs based on technical expertise as well as other pertinent DOH offices, and
attached agencies as mentioned in this order (Refer to Annex A). <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">DEFINITION OF TERMS:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l8 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratories (NRLs)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – the highest level of laboratory in the country performing high complex
procedures including confirmatory testing that it not commonly performed by the
lower level of laboratory. It is the responsible entity for facilitating
National External Quality Assessment Scheme (NEQAS) to ensure compliance of
quality standards for regulation and licensing of all laboratories in the
Philippines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l8 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National External Quality Assessment Scheme (NEQAS)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – a quality assurance activity conducted by the NRLs
to assess the quality of performance and accuracy of test results of
laboratories. It is used as a requirement of laboratories for the renewal of
license to operate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l8 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">In–vitro Diagnostic Medical Device (IVDMD)</span></b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"> – any reagent, reagent product, calibrator, control material, kit,
instrument, apparatus, equipment, or system, whether used alone or in
combination, intended by the manufacturer to be used in vitro for the
examination of specimens, including blood and tissue donation, derived from the
human body, solely or principally for the purpose of providing information on:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Physiological or pathological state<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Congenital abnormality <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Safety and compatibility of donations, including blood and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l15 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Therapeutic measures</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">and includes a specimen receptacle but not a produce for general
laboratory use, unless that product, in view of its characteristics, is
specifically intended by its product owner to be used for in vitro diagnostic
examination. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">GENERAL GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The DOH shall provide standards in ensuring quality laboratory services
to guide laboratory testing procedures in all levels of care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">NRLs shall provide improved access to quality, specialized health
laboratory services in their respective areas of technical expertise, to cater
to the needs of and which is not otherwise available in other tertiary category
health laboratory facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l16 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">NRLs shall be strengthened to provide support to the sub–national,
regional, public health laboratories, and referral networks of health
laboratory facilities based on service mandates. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SPECIFIC GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l21 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">To provide an enabling mechanism for the institutionalization and
operation of the NRLs:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRLs shall be recognized as an operational unit with well–defined organizational
structure and mandate distinct from the functions and operations of the host
hospital’s general clinical laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRL operations shall be included as a line item in the National
Budget for the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Upon approval of the requested positions from the Department of Budget
and Management, the NRLs shall ensure adequate staffing complement to include
the following: management staff, technical staff, and support staff (i.e., data
management, administrative, information technology, and biomedical
engineering).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRL shall be provided with additional operational budget for
functions related to national programs of the DOH especially during pandemics
and outbreaks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRLs shall retain 100% of its self–generated income and shall
incorporate in their Work and Financial Plan (WFP) the contributions to the
host hospital to cover for operational expenses which may include but are not
limited to utilities (i.e., electricity, water, telephone, internet), supplies,
use of other hospital facilities, and other preventive maintenance fees.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l21 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">To strengthen the capacity and capability of NRLs:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRL shall be capacitated with state–of–the–art equipment, infrastructure,
and application software suitable for reference laboratory work.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRL shall work within the efficient and effective Quality Management
Systems of its host hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRL shall be provided with quality supplies, reagents, quality
control materials, reference standards and other laboratory supplies for appropriate
reference laboratory work; relevant training, continuing education and
participation in pertinent avenues for learning and development of NRL staff locally
and internationally; appropriate infrastructure, equipment and laboratory facilities;
avenues for linkages with networks and partnerships with national and
international agencies and reference laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l0 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The NRL shall attain certification and accreditation to international
quality standard relevant to its operation, to include but not limited to: ISO
9001 (Quality Management System); <a href="https://mt-lectures.blogspot.com/2019/01/iso-15189-medical-laboratories_14.html" target="_blank">ISO 15189</a> (Medical
Laboratories – Particular Requirements for Quality Standards and Competence);
<a href="https://mt-lectures.blogspot.com/2023/02/iso-17043.html" target="_blank">ISO/IEC 17043</a> (General Requirements for the
Competence of Providers of Proficiency Testing Schemes); <a href="https://mt-lectures.blogspot.com/2023/03/iso-17025-self-assessment-compliance.html" target="_blank">ISO/IEC 17025</a> (General Requirements for the Competence of
Testing and Calibration Laboratories). <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">ROLES AND RESPONSIBILITIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratories (NRLs):</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide laboratory referral services, e.g., for confirmatory testing,
surveillance, outbreak response, and research.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Administer the NEQAS to assess the quality of performance and test
results of clinical laboratories in collaboration with the Health Facilities
and Services Regulatory Bureau.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Conduct training to upgrade knowledge and improve the skills of
laboratory personnel.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Evaluate IVDMD to include reagents in collaboration with the Food and
Drug Administration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provide technical assistance to the DOH, other government agencies,
private sector, and international partners, as the need arises.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Implement surveillance systems to provide critical inputs as guide to
DOH policies and stakeholders’ response and activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Assess and recommend to the DOH the establishment of subnational reference
laboratories, public health laboratories in areas that need special test not done
by a general clinical laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l13 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Participate in the Service Delivery Network as the highest level of
laboratory services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Health Facility Development Bureau (HFDB):</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Develop plans, policies, programs, projects, and strategies related to
health facility development, planning, operation, and maintenance of NRLs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provides technical assistance in the development and strengthening of
all NRLs through capability building and advisory services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Acts as the secretariat to the National Health Laboratory Network and
its Technical Working Groups.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensures funds and other resources are provided for the development of
NRLs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Consolidate, analyzes, and transmits accomplishment reports of the NRLs
to the DOH Management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l3 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Supports the achievement of quality and accessible healthcare facilities
for better health outcomes as one of the goals of the Universal Health Care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Host Hospitals where NRLs are lodged:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l20 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Includes NRLs in the Operational Plans of the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l20 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Ensures adequate funds are allocated for the continuous operation of the
NRLs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l20 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Provides administrative support, human resources, and physical infrastructure
dedicated to NRLs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Health Facilities and Services Regulatory Bureau (HFSRB)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l9 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Enforces the effective implementation and participation of laboratories
in the NEQAS program of the NRLs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l5 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Food and Drug Administration (FDA):</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt; mso-list: l22 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Coordinates with the appropriate NRL for the technical evaluation of <a href="https://mt-lectures.blogspot.com/2018/06/republic-act-no-3720.html" target="_blank">In–VitroDiagnostic Medical</a> Devices prior to the issuance of the Certificate of Product
Registration, when necessary. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="font-size: large;"><span style="color: #01ffff;">Department Order 393–E s. 2000 dated November 14, 2000 entitled “Designation
of National Reference Laboratories and Transfer of Corresponding Equipment,
Instruments, Supplies, Specimens, Records from the Bureau of Research Laboratories
to the Designated National Reference Laboratories,” Department Personnel Order 2009
– 5148 dated December 21, 2009 entitled “Amendment to Department Order 393–E s.
2000 dated November 14, 2000 regarding Designation of National Reference Laboratories
and Transfer of Corresponding Equipment, Instruments, Supplies, Specimens,
Records from the Bureau of Research Laboratories to the Designated National Reference
Laboratories” are </span><span style="color: #fcff01;">hereby repealed and rescinded</span></span><span style="color: #01ffff; font-size: large;"> accordingly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">All other provisions of the Department Order 2010 – 0254 entitled “Guidelines
for the Use of Revenues Collected and Earned from the Conduct of Activities by
the National Reference Laboratories” and its amendment, Department Order 2010 –
0254–A, which are not affected by this order shall remain valid and in effect.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">SEPARABILITY CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">If any portion or provision of this order is held valid or unconstitutional,
the same shall not affect the validity and effectiveness of the provisions hereof.
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l11 level1 lfo1; text-indent: -36.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">X.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall take effect fifteen (15) days after posting in the
Official Gazette or in a newspaper of general circulation.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO T. DUQUE III, MD,
MSc<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Secretary of Health</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX A<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">LIST OF HOSPITAL WITH THEIR DESIGNATED NATIONAL
REFERENCE LABORATORIES BASED ON TECHNICAL EXPERTISE</span></span></b></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">East Avenue Medical Center</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l1 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Environmental & Occupational
Health <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l1 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Toxicology<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l1 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Micronutrient Assay<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l1 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Industrial and Chemical Emergencies <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Lung Center of the Philippines</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l2 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for General Clinical Chemistry <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l2 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Anatomic Pathology for Pulmonary and
Pleural Diseases<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Kidney and Transplant Institute</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Hematology <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Immunohematology <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Urinalysis <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Anatomic Pathology for Renal Diseases
and other Unassigned Organ Systems<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l12 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Cellular–Based Product Testing (A.O.
No. 2013 – 0012, “Rules and Regulations Governing Accreditation of Health
Facilities Engaging in Human Stem Cell and Cell Based or Cellular Therapies in
the Philippines”)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Philippine Heart Center</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l18 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Anatomic Pathology for Cardiac
Diseases<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l18 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Cardiac Markers <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Research Institute for Tropical Medicine</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory Antimicrobial Resistance <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Tuberculosis Reference Laboratory<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Transfusion – Transmissible Infections
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Dengue and Other Arboviruses *<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Influenza and Other Respiratory
Viruses *<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Emerging and Re–emerging Bacterial
Diseases *<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Leptospirosis*<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Special Pathogens*<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Mosquito Vectors of Human Diseases*<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Malaria and Other Parasites**<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Schistosomiasis**<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">l.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Rabies and Other Lyssaviruses**<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">m.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Polio and other Enteroviruses<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">n.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Measles and other Exanthems<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">o.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Invasive Bacterial Vaccine Preventable
Diseases <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">p.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Rotavirus and other Enteric Viruses
*** (A.O. No. 2015 – 0050 “Designation of RITM as the National Reference Laboratory
for Rotavirus and other Enteric Viruses)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">q.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Bacterial Enteric Diseases ***<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l4 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">r.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Mycology</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">*These NRLs shall support the Emerging and Re–emerging Infectious Disease
Control Program <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">** These NRLs shall support the Neglected Tropical Disease Control
Program <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">***These NRLs shall support the Food and Waterborne Disease Control Program<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l7 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">San Lazaro Hospital – STD AIDS Cooperative Central Laboratory (SACCL):</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for HIV/AIDS<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">National Reference Laboratory for Hepatitis B and Hepatitis C<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54.0pt; mso-list: l19 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">National Reference Laboratory for Syphilis and other sexually – Transmitted
Infections</span><span style="font-size: 12pt;"><o:p></o:p></span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com1tag:blogger.com,1999:blog-1102712979345561714.post-44546754723271871822023-05-08T20:59:00.000+08:002023-05-08T20:59:39.931+08:00Department Circular No. 2021 – 0511<p><span style="color: #01ffff; font-size: large;"> <span style="font-family: "Palatino Linotype", serif;">29 October 2021</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><br /></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">CLARIFICATIONS ON THE ROLES AND FUNCTIONS OF
REGISTERED RESPIRATORY THERAPISTS, REGISTERED MEDICAL TECHNOLOGISTS AND HEAD OF
CLINICAL LABORATORY</span></span></b></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></b></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Administrative Order No.
2021 – 0037, titled, “New Rules and Regulations Governing the Regulation of
Clinical Laboratories in the Philippines,” was issued on June 11, 2021,
published on July 7, 2021, and took effect on July 22, 2021. Section V.F. of
the General Guidelines states that <i>“Unit/Section of health facilities
performing diagnostic CL (Clinical Laboratory) tests such as, but not limited
to, arterial blood gas and/or Radioimmunoassay for thyroid function tests and
Prostate Specific Antigen shall be under the DOH–licensed CL.”</i></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="font-size: large;"><span style="color: #01ffff;">Arterial Blood Gas (ABG),
being vital in the critical management of patients, is usually performed as
Point of Care Testing (POCT). Processing of the specimen is usually done either
in the Pulmonary Laboratory or in the main Clinical Laboratory. Respiratory
Therapists, based on their law, Republic Act No. 10024, titled, “An Act
Regulating the Practice of Respiratory Therapy, creating a Professional
Regulatory Board of Respiratory Therapy, Appropriating Funds Therefor and for
Other Purposes,” issued on March 9, 2010, </span><span style="color: #fcff01;">contended
that it is their domain and should not be under the Clinical Laboratory.</span></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">However, Section 1 of
Republic Act (R.A.) 4688 titled, “An Act Regulating the Operation and
Maintenance of Clinical Laboratories and Requiring Registration of the Same
with the Department of Health, Providing Penalty for the Violation Thereof, and
for Other Purposes,” specifically states that, <i>“Any person, firm or
corporation, operating and maintaining a clinical laboratory in which body
fluids, tissues, secretions, excretions and radioactivity from being or animals
are analyzed for the determination of the presence of pathologic organisms, processes
and/or conditions in the person or animals from which they are obtained, shall
register and secure a license annually at the office of the Secretary of
Health.”</i></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The following guidelines are
being issued to clarify the roles of the relevant personnel, namely the
Respiratory Therapist Registered in the Philippines (RTRP), Registered Medical
Technologist (RMT), Head of Clinical Laboratory (HOCL):</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Extraction of blood for ABG analysis shall either be done by
professionally trained personnel such as Medical Doctor (MD), Respiratory
Therapist Registered in the Philippines (RTRP) and Registered Medical
Technologist (RMT).</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Processing of specimen for ABG analysis can either be done at the
Respiratory/Pulmonary Unit by the RTRP, as Point–of–care testing (POCT), or at
the CL by the RMT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">ABG result shall be interpreted by the patient’s attending Physicians
and referred to the Pulmonologist, as the nee arises.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">The Head of the CL shall exercise oversight functions on the section of
the Respiratory/Pulmonary Unit that analyzes/processes the ABG, which include
but not limited to, quality control of equipment/instrument and supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">All results whether processed at the Respiratory/Pulmonary Unit as POCT
or at the main CL, shall be signed by the Head of the Clinical Laboratory or
the designated Associate Clinical Pathologists, in the absence of HOCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span lang="EN-US" style="font-family: "Palatino Linotype", serif;">Releasing of official results shall be done by the unit/section which
processed the tests (Clinical Laboratory or Respiratory/Pulmonary Unit).</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">For strict compliance and
dissemination.</span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ATTY. CHARADE B MERCADO –
GRANDE<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Undersecretary of Health<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Health Regulation Team <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><i><span style="color: #01ffff; font-size: large;">(There
should also be a distinction between the Radioimmunoassay done in the Clinical Laboratory
to the Radioimmunoassay done in Nuclear Medicine. Both are performed by RMT but
signed by Endocrinologist in the Nuclear Medicine and by a Pathologist in a CL)</span></i></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-13098993484441880232023-05-08T15:42:00.002+08:002023-12-13T19:01:12.941+08:00Administrative Order No. 2021 – 0037<p><span style="color: #01ffff; font-size: large;"> <span style="font-family: "Palatino Linotype", serif;">11
June 2021</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NEW RULES AND
REGULATIONS GOVERNING THE REGULATON OF CLINICAL LABORATORIES IN THE PHILIPPINES</span></span></b></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">RATIONALE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">By virtue of <a href="https://mt-lectures.blogspot.com/2017/08/republic-act-no-4688.html" target="_blank">RepublicAct No. 4688</a> s. 1966, “An<span style="mso-spacerun: yes;"> </span>Act
Regulation the Operation and Maintenance of Clinical Laboratories and Requiring
the Registration of the Same with the Department of Health, Providing Penalty
for Violation Thereof, and for Other Purposes,” the Department of Health (DOH)
through the Bureau of Medical Services, now known as the <b>Health Facilities
and Services Regulatory Bureau (HFSRB)</b>, was mandate to ensure public
health, safety and welfare through enforcement of the Act and was authorized to
issue such rules and regulations as may be necessary to carry out the law.
Clinical laboratory services play an important role in the diagnosis,
treatment, prevention, and control of disease. Thus, it is imperative that the
laboratories generate accurate, precise, and reliable laboratory test results
in a timely manner to aid the Physicians in assuring the quality of patient
care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: large;"><span style="color: #01ffff;">Through the years, several laboratory
technological advancements have been introduced. As such, certain provisions in
the current <a href="https://mt-lectures.blogspot.com/2017/08/administrative-order-no-2007-0027.html" target="_blank">Administrative Order (AO) No. 2007 – 0027</a>, dated August 22, 2007,
titled “Revised Rules and Regulations Governing the Licensure and Regulation of
Clinical Laboratories in the Philippines,” may have become </span><b><span style="color: #fcff01;">outdated</span></b><span style="color: #01ffff;">.
This policy is being issued to align the laboratory procedure with the requirements
of A.O. 2020 – 0047 titled “Rules and Regulations Governing the Licensure of
Primary Care Facilities in the Philippines.”</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The necessity to review the current A.O.
and to revise and update the minimum standards and technical requirements for
licensing clinical laboratories in the Philippines is aligned with the main
objective of <a href="https://mt-lectures.blogspot.com/2020/08/republic-act-no-11223.html" target="_blank">Republic Act No. 11123</a> or the Universal
Health Care Act which is to guarantee access to quality and affordable
health products, devices, facilities, and services. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">OBJECTIVE</span></b><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">These rules and regulations shall serve
as the new guidelines in the licensing of diagnostic clinical laboratories in
the Philippines which shall ensure accountability of the laboratory on
generation of accurate, precise, and reliable results in a timely manner
through continuous compliance. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SCOPE OF
APPLICATION</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall apply to all
individuals, agencies, partnerships, or corporations whether private or
government–owned, involved in the application for DOH license to operate and
those in the operation of diagnostic clinical laboratories in the Philippines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall also apply to
Bangsamoro Autonomous Region in Muslim Mindanao (BARMM) subject to the
applicable provisions of R.A. 11054 or the Bangsamoro Organic Act” and
subsequent rules and policies issued by the Bangsamoro Government. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">DEFINITION OF TERMS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Applicant
</span></b><span style="font-family: "Palatino Linotype", serif;">–
refers to any natural juridical person, government instrumentalities/agencies,
partnership, corporation, or agency seeking license to operate and maintain a
clinical laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Assessment
Tool</span></b><span style="font-family: "Palatino Linotype", serif;">
– the checklist which prescribes the minimum standards and requirements for
licensure of a clinical laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Clinical
Laboratory (CL)</span></b><span style="font-family: "Palatino Linotype", serif;">
– a facility that is involved in the (a) pre– analytical, (b) analytical, (c)
and post–analytical procedures, where tests are done on specimens from the human
body to obtain information about the health status of a patient for the
prevention, diagnosis, and treatment of diseases. These tests include, but are
not limited to, the following disciplines: anatomic pathology, clinical
chemistry, clinical microscopy, endocrinology, hematology, immunology and
serology, microbiology, toxicology, as well as molecular and nuclear
diagnostics.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Department
of Health – License to Operate (DOH – LTO)</span></b><span style="font-family: "Palatino Linotype", serif;"> – a formal authorization issued
by the DOH to an individual, partnership, corporation, association, or any
government agency/unit seeking to perform laboratory tests in the compliance
with the requirements prescribed in this Order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Department
of Health – Permit to Construct (DOH – PTC)</span></b><span style="font-family: "Palatino Linotype", serif;"> – a permit issued by DOH through
HFSRB or Center for Health Development Regulation, Licensing and Enforcement
Division (CHD – RLED) to an applicant who will establish and operate a hospital
or health facility, upon compliance with required documents prior to the actual
construction of the said facility. A DOH – PTC is also required for hospitals
and other health facilities with substantial alteration, expansion, renovation,
increase in the number of beds, transfer of site, or for additional services
(add–ons) beyond their service capability. It is a prerequisite for License to
Operate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">External
Quality Assessment Program (EQAP)</span></b><span style="font-family: "Palatino Linotype", serif;"> – a program where participating CL are
given unknown samples for analysis. These samples should be treated as ordinary
human specimens for the usual processing and examination. The quality of
performance of the CL shall be assessed through the closeness of its results to
the pre–determined value or reference value generated by the participating CL
through peer group analysis.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Initial
Application</span></b><span style="font-family: "Palatino Linotype", serif;">
– refer to application by newly constructed health facilities, or those with
changes in the circumstances of the facility, such as, but not limited to,
change of ownership, transfer of site, increase in beds or for additional
services beyond their service capability and major alterations or renovations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Mobile
Clinical Laboratory (MCL)</span></b><span style="font-family: "Palatino Linotype", serif;"> – a laboratory testing unit capable of performing
limited CL diagnostic procedures. It moves from one testing site to another,
and it has a DOH–licensed CL as its main laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">National
External Quality Assessment Scheme (NEQAS)</span></b><span style="font-family: "Palatino Linotype", serif;"> – an EQAP activity conducted by
the National Reference Laboratories to assess the quality of performance and
accuracy of the results of laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">National
Reference Laboratory (NRL)</span></b><span style="font-family: "Palatino Linotype", serif;"> – the highest level of laboratory in the country
performing highly complex procedures, including confirmatory testing, that is
not commonly performed by the lower level of laboratory. It is the responsible
entity for facilitating NEQAS to ensure compliance to quality standards for
regulation and licensing of all laboratories in the Philippines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">K.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Physician’s
Office Laboratory (POL)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to a doctor’s office/clinic wherein CL
examinations are performed for the purpose of monitoring the doctor’s patient’s
only, wherein NO official result shall be issued. In this Order, POL within the
premises of a DOH–regulated facility shall be under the supervision of the CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">L.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Point
of Care Testing (POCT)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to a diagnostic testing done at or near
the site of patient care rather than in the CL. It maybe in the emergency room,
operating suites, wards, and ambulances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">M.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Satellite
Clinical Laboratory (SCL)</span></b><span style="font-family: "Palatino Linotype", serif;"> – refers to an extension of the main CL located
within the facility’s compound or premises. It shall have the same service
capability as the main laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">N.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Referral
Tests</span></b><span style="font-family: "Palatino Linotype", serif;">
– refers to CL tests that are either sent–out or outsourced to other
DOH–licensed CL with the same or higher service capability. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">All
CL shall secure DOH – LTO prior to its operation and must always comply with
the minimum regulatory standards and requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
DOH – LTO shall be secured from the DOH regulatory office in accordance with
DOH guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Only
DOH–licensed CL may have a SCL which shall be located within the premises of
the regulated health facility.<span style="mso-spacerun: yes;"> </span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
DOH–licensed CL may have MCL services as listed in Section IV of Annex A,
provided, they adhere to the standard testing protocols.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
DOH–licensed CL shall not perform any examinations or testing beyond its
authorized service capability. However, it may be allowed to offer laboratory
services other than the respective stipulated minimum services such as but not
limited to, MCL, SCL, confirmatory testing for Glucose–6–Phosphate
Dehydrogenase (G6PD) Deficiency, and Rapid HIV Diagnostic Algorithm (rHIVda),
provided that the additional services have been approved and indicated as
add–ons services in the DOH – LTO of the CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Unit/Section
of health facilities performing diagnostic CL test such as, but not limited to,
arterial blood gas and/or Radioimmunoassay for Thyroid Function Tests and
Prostate Specific Antigen shall be under the DOH– licensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
head of the CL shall be a Pathologist certified by a professional organization
recognized as the Accredited Professional Organizations/Accredited Integrated
Professional Organizations of the Professional Regulation Commission. The head
of laboratory shall ensure the optimal overall operations and maintenance of
the CL and if applicable, of its SCL and MCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">There
shall be an adequate number of competent personnel assigned in the different
services provided by the DOH–licensed CL, which includes the MCL, SCL, remote
collection activities, if applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">CLs
that are operated and maintained exclusively for research and teaching purposes
shall be required to register with the DOH – HFSRB.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">J.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
DOH designated NRL shall be covered by the license of the CL of the hospital
where they are affiliated with. Independent NRLs, or those designated by DOH
but are not affiliated with any DOH–regulated health facility, shall secure a
DOH – LTO from HFSRB.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">K.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">All
CLs shall make their prices for laboratory services accessible to the public as
mandated by the UHC Law and related DOH issuances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">L.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">At
the Central Office, the Director IV, or in his/her absence or unavailability or
when delegated, the Director III of HFSRB, shall approve the issuance of the
DOH – LTO of the CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">M.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">At
the CHD, the Director IV, shall approve the issuance of the DOH – LTO of the
CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">N.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">In
the advent of new technologies or diagnostic platforms that shall affect the
current licensing standards for CL, Department Circulars shall be issued, as
needed, as supplements to this Order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">O.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
CL shall be compliant with the prescribed standards and requirements (Annex A),
Assessment Tool for Licensing Clinical Laboratories (Annex B1 and B2) and other
relevant laws and issuances. These standards shall also apply to MCLL and SCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l9 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">P.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
DOH – LTO may be revoked, suspended, or modified in full or in part for any
false statement by the applicant, or as shown by the record of inspection or
for violation of, or failure to comply with any of the terms and conditions and
provisions of these rules and regulations.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l3 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Classification
of Clinical Laboratories</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Classification
by Ownership</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Government</span></b><span style="font-family: "Palatino Linotype", serif;"> – operated and
maintained, partially or wholly, by the national government, a local government
unit (provincial, city or municipal), any other political unit or any
department, division, board, or agency thereof.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Private</span></b><span style="font-family: "Palatino Linotype", serif;"> – privately
owned, established, and operated with funds through donation, principal,
investment, or other means, by an individual, corporation, association, or
organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Classification
by Institutional Character</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Institution–based</span></b><span style="font-family: "Palatino Linotype", serif;"> – a laboratory
that is located within the premises and operates as part of a DOH licensed
health facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Non–institution
based</span></b><span style="font-family: "Palatino Linotype", serif;">
– a laboratory that operates independently and is not attached to any DOH
licensed health facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Classification
by Function</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l13 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
Pathology</span></b><span style="font-family: "Palatino Linotype", serif;">
– deals with the chemical and cellular analyses of blood and other body fluids
(includes, but not limited to, clinical chemistry, clinical microscopy,
toxicology, therapeutic drug monitoring, immunology, and serology, hematology
and coagulation), identification and examination of microbes and parasites
(bacteriology/parasitology/mycology/virology).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l13 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Anatomic
Pathology</span></b><span style="font-family: "Palatino Linotype", serif;">
– provides processing and examination of surgical specimens as to the physical
appearance and microscopic structure of tissues, such as, but not limited to,
surgical pathology, cytopathology, immunohistochemical techniques, autopsies,
and forensic pathology.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l13 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Molecular
Pathology</span></b><span style="font-family: "Palatino Linotype", serif;">
– deals with the analysis of certain genes, proteins, and other molecules in
samples from organs, tissues, or bodily fluids to diagnose disease and/or to
guide the prevention and treatments of disease based on the principles, techniques,
and tools of molecular biology as they are applied to diagnostic medicine in
the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l24 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Classification
by Service Capability</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l8 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
Laboratory for Clinical and Anatomic Pathology</span></b></span></p>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; margin-left: 90pt; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 70.85pt;" valign="top" width="94">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 72.85pt;" valign="top" width="97">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Provides
the following minimum service capabilities:<o:p></o:p></span></span></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 65.35pt;" valign="top" width="87">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Provides
the minimum service capabilities of a primary category plus the following:<o:p></o:p></span></span></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 71.7pt;" valign="top" width="96">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Provides
the minimum service capabilities of a secondary category plus the following:<o:p></o:p></span></span></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 80.05pt;" valign="top" width="107">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Provides
one (1) or two (2) specialized tests that are not classified under Anatomic
or Molecular Pathology as exemplified below:<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 70.85pt;" valign="top" width="94">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Clinical
Microscopy<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 72.85pt;" valign="top" width="97">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Urinalysis<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Fecalysis<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Fecal Occult Blood Test<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Pregnancy Test (Rapid Test Kits – Lateral Flow)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Wet Smear for Trichomonas<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 65.35pt;" valign="top" width="87">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 71.7pt;" valign="top" width="96">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td rowspan="3" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 80.05pt;" valign="top" width="107">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Molecular
Pathology as exemplified below: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Hormones <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Trace Metals <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Tumor Markers <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Allergy Panel <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif;">–
This classification shall also apply to facilities offering DOH –program
related tests, e.g. Kato Katz for Schisotosomiasis, Malarial Smear, Filaria
Smear, Slit– skin smear, Rapid Plasm Reagin for Syphilis </span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 70.85pt;" valign="top" width="94">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Clinical
Chemistry<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 72.85pt;" valign="top" width="97">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Fasting and Random Blood Sugar <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Oral Glucose Tolerance Test <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Lipid Profile (Total Cholesterol, HDL, LDL, Triglycerides)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Creatinine<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Blood Urea Nitrogen <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Blood Uric Acid <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 65.35pt;" valign="top" width="87">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Serum Electrolytes (Sodium, Potassium, Chloride)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
ALT<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
AST<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 71.7pt;" valign="top" width="96">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Other Clinical Chemistry Examinations<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Hospital
– based: Arterial Blood Gases <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 70.85pt;" valign="top" width="94">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Hematology<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 72.85pt;" valign="top" width="97">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Complete Blood Count (Hemoglobin, Hematocrit, Red Blood Cell Count, White
Blood Cell Count with Differential Count, Quantitative Platelet count)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Forward and reverse ABO grouping and Rh (D) typing (tube method)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 65.35pt;" valign="top" width="87">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">For
Hospital – based: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Coagulation studies (PT, aPTT)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 71.7pt;" valign="top" width="96">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 70.85pt;" valign="top" width="94">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Serology/<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Immunology<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 72.85pt;" valign="top" width="97">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Dengue<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Syphillis<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Hepatitis B (Screening) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
HIV (Screening) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Using
Rapid Test Kits <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 65.35pt;" valign="top" width="87">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 71.7pt;" valign="top" width="96">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 80.05pt;" valign="top" width="107">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Any
machine – based serological and immunological test such as, but not limited
to: tumor markers, thyroid function tests and hepatitis profile<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 70.85pt;" valign="top" width="94">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Microbiology<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 72.85pt;" valign="top" width="97">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
TB (DSSM) or Nucleic Acid Amplification Test – for government facilities <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 65.35pt;" valign="top" width="87">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Gram Stain<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
KOH<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 71.7pt;" valign="top" width="96">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 80.05pt;" valign="top" width="107">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif;">– Culture
and sensitivity (aerobic and anaerobic) </span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 70.85pt;" valign="top" width="94">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Anatomic
Pathology<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 72.85pt;" valign="top" width="97">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 65.35pt;" valign="top" width="87">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Pap smear<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 71.7pt;" valign="top" width="96">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 80.05pt;" valign="top" width="107">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">For
Hospital – based: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">–
Cytology and Histopathology<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l8 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
Laboratory for Anatomic Pathology only</span></b><span style="font-family: "Palatino Linotype", serif;"> – provides services for any of the
following, but not limited to cytology and histopathology.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l8 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Clinical
Laboratory for Molecular Pathology only</span></b><span style="font-family: "Palatino Linotype", serif;"> – provides services for genetics,
immuno/hematopathology and infectious disease. COVID–19 testing laboratories
shall be covered by another order. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">PROCEDURAL
GUIDELINES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Permit
to Construct</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
filled-out application form for DOH – PTC (downloadable at </span><span style="font-family: "Palatino Linotype", serif;"><a href="https://hfsrb.doh.gov.ph/licensing-accreditation-of-health-facilities-and-services/" target="_blank">www.hfrsb.doh.gov.ph</a></span><span style="font-family: "Palatino Linotype", serif;">), whether
manual or online, shall be submitted to the DOH regulatory offices, as
specified in Section V.B of this Order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
DOH – PTC shall be required for construction of a new CL and for renovation or
expansion of existing CL, including change in ownership and transfer of
location.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l1 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
application shall be processed in accordance with the procedural guidelines set
forth in A.O. No. 2016 – 0042, also known as,
“Guidelines in the Application for Department of Health Permit to Construct
(DOH – PTC).”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">License
to Operate (LTO)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Any
person, firm or corporation desiring to establish, operate, and maintain CL
shall submit an accomplished application form to HFRSB/CHD – RLED in accordance
with the current DOH guidelines, whether manual or through the Online Licensing
and Regulatory System (OLRS), once it is fully functional.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
complete application for DOH – LTO or CL shall consist of the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Completely
filled out application Form 1 and its attachments (downloadable at </span><span style="font-family: "Palatino Linotype", serif;"><a href="https://hfsrb.doh.gov.ph/licensing-accreditation-of-health-facilities-and-services/" target="_blank">www.hfrsb.doh.gov.ph</a></span><span style="font-family: "Palatino Linotype", serif;">);</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l25 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(1)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Notarized
Acknowledgement <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l25 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(2)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
of the following proof of ownership and name of health facility <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126pt; mso-list: l0 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">DTI/SEC/CDA Registration
including Articles of Incorporation/Cooperation and By – laws<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 126pt; mso-list: l0 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Enabling Act/LGU Resolution (for
government health facility) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l25 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(3)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Accomplished
Self–Assessment Tool <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt; mso-list: l25 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">(4)<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Health
Facility Geographic Form</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Copy
of Official Receipt payment</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Certificate
from NRL – SLH/SACCL for rHIVdaA Confirmatory, if applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l18 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Certificate
from Newborn Screening Reference Center (NSRC), if applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Upon
receipt of the complete application forms, the HFRSB/CHD – RLED representative,
in accordance with the current DOH guidelines, reviews the application and
conducts an on–site assessment of the laboratory to determine full compliance
with the standards and technical requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
upon assessment, the laboratory is not fully compliant with the licensing
requirements, the HFRSB/CHD – RLED, in accordance with the current DOH
guidelines, shall provide a written report outlining the laboratory’s
deficiencies. The laboratory must comply with the deficiencies withing thirty
(30) days. Otherwise, the application shall automatically be denied.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
DOH – LTO, whether initial or renewal, shall only be issued after the HFRSB/CHD
– RLED, in accordance with the current DOH guidelines, has determined that the
laboratory is fully compliant.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submitted
complete applications that are not processed within twenty (20) days by the
HFRSB/CHD – RLED, in accordance with the current DOH guidelines, due to force
majeure, shall automatically be granted the LTO, and a post–licensing visit
shall be scheduled.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Only
DOH licensed CL identified by the program and has already secured a certificate
of “Certified rHIVda Confirmatory Laboratory (CCL)” from the NRL – SLH/SACCL or
its designated regional counterpart, shall be allowed to apply for a license
CrCL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">A
DOH – licensed hospital – based tertiary CL, already certified by the NSRC, may
apply as G6PD Deficiency confirmatory laboratory to HFRSB.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">For institution–based CL, the One–Stop Shop (OSS) Licensing System,
pursuant to Administrative Order No. 2018 – 0016 dated June 4, 2018, titled
“Revised Guidelines in the Implementation of the One–Stop Shop Licensing
System,” shall be followed. The DOH-LTO of the institution based CL shall be subsumed in the DOH-LTO of the health facility.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
DOH – LTO is non–transferable and a new application for DOH – LTO shall be
required in case of change of ownership or transfer of location.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
HFRSB/CHD – RLED, in accordance with the current DOH guidelines, shall be
notified in writing of any change in management name, ownership or headship or
laboratory personnel. Failure to notify of any substantial change in the
condition of the laboratory, i.e., changes in the physical plant, equipment, or
personnel, in writing within fifteen (15) days, may be a basis for the
suspension or revocation of the DOH – LTO.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">12.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Different
branch(es) of a CL, even if owned by the same entity shall secure separate DOH
– LTO.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">13.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Application
for DOH – LTO shall follow A.O. No. 2019 – 0004 dated
April 30, 2019, titled “Guidelines on the Annual Cut–off Dates for Receipt of
Complete Applications for Regulatory Authorizations Issued by the Department of
Health.”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l2 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">14.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
DOH – LTO shall be placed in an area that can be readily seen by the public, always.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Certificate
of Registration (COR)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l6 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">COR
is required for research and teaching laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l6 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Applicants
shall submit an accomplished registration form (downloadable at </span><span style="font-family: "Palatino Linotype", serif;"><a href="https://hfsrb.doh.gov.ph/licensing-accreditation-of-health-facilities-and-services/" target="_blank">www.hfrsb.doh.gov.ph</a></span><span style="font-family: "Palatino Linotype", serif;">) together with
the necessary attachments to HFSRB, which includes Annex for services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l6 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
applicant shall be required to pay a non–refundable application fee before
submission of the requirements as part of complete application.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l6 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HFSRB shall evaluate and accept applications based on the due execution of
forms and completeness of attachments.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Validity</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l10 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
DOH – LTO is valid for one (1) year.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l10 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">COR
for CL that is operated and maintained exclusively for research and teaching
purposes shall be required to register with the DOH – HFSRB every three (3)
years.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Fees</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l21 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
fees shall follow the prescribed fees by the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l21 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
fees/checks shall be paid to the order of DOH Central Office/CHD Cashier,
whichever is applicable in person, through postal money order or online
payments approved by the DOH.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l21 level1 lfo18; text-indent: -18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Monitoring</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Authorized
representatives from the HFRSB/CHD – RLED in accordance with the current DOH
guidelines, may conduct unannounced on–site visits of licensed CL and
registered research and teaching laboratories to monitor and document the
continuous compliance of the CL to the set standards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">If
upon monitoring visit, the CL is found to be violating any of the rules and
regulations stated herein relative to its operation, the HFSRB/CHD – RLED in
accordance with the current DOH guidelines, may immediately impose preventive
suspension.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l20 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">CL
that are operated and maintained exclusively for research and teaching purposes
shall not issue official results for diagnostic purposes. They may be monitored
to ensure that they are not operating beyond allowed capabilities. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">ROLES
AND RESPONSIBILITIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l12 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Health
Facilities and Services and Regulatory Bureau shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l17 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Set
standards for the regulation of CL and strictly enforce the provisions of this
order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l17 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Disseminate
regulatory policies, standards, and forms for information and guidelines of the
DOH – CHDs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l17 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
consultation and technical assistance to stakeholders, including regulatory
officers from the DOH – CHDs in line with the regulations of CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l17 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Respond
promptly to complaints relative to the operation of CL under its jurisdiction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l12 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Center
for Health Development – Regulatory, Licensing and Enforcement Division shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l26 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Strictly
enforce the provision of this Order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l26 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Submit
quarterly report on Suspension/Revocation/Cease and Desist Order issued on CL
not later than the 15<sup>th</sup> day of the following month after the covered
quarter.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l26 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
consultation and technical assistance to stakeholders in line with the
regulations of CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l26 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Respond
promptly to complaints relative to the operation of CL under its jurisdiction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l12 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">National
Reference Laboratories shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l23 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Provide
laboratory reference/referral services for confirmatory testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l23 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Train
laboratory personnel and recognize other training institutions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l23 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Maintain
the National External Quality Assessment Scheme (NEQAS).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l23 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Perform
technical evaluation of reagents and diagnostic kits.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l12 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">DOH–licensed
Clinical Laboratories shall:</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l14 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Continuously
comply with the rules and regulations, licensing standards and requirements for
CL, as provided in this Order and related issuances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l14 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Participate
in EQAP that may be administered by a designated NRL or other local and
international EQAP approved by the DOH, surveys, and other activities that will
be required from them by the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l14 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
times of Pandemic of Public Health Event, be mandated to submit timely reports
and data. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">IX.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">VIOLATIONS,
SANCTIONS AND APPEAL</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
CL shall be sanctioned and penalized by the HFSRB/CHD Director upon violation
of any these guidelines and its related issuance and laws, or upon committal
(commission/omission) of prohibited acts (Annex C) by the persons owning or
operating the CL, and/or the persons under their authority.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
non–institution–based CL that are not under the OSSOLS, the following are the
penalties and sanctions that shall be imposed for the commission of any the
violations in this Order and other relevant issuances:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l11 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">1<sup>st</sup>
Offense:<span style="mso-tab-count: 1;"> </span>Stern Warning <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l11 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">2<sup>nd</sup>
Offense:<span style="mso-tab-count: 1;"> </span>Thirty thousand pesos (Php
30,000.00) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l11 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">3<sup>rd</sup>
Offense:<span style="mso-tab-count: 1;"> </span>Fifty thousand pesos (Php
50,000.00) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l11 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">4<sup>th</sup>
Offense:<span style="mso-tab-count: 1;"> </span>Revocation of DOH – LTO</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">For
CL that are part of hospital and other facilities that are subject to comply
with the OSS Licensure system, A.O. No. 2007 – 0022,
dated June 6, 2007, titled “Violations under the One–Stop Shop Licensure System
for Hospitals,” sanctions shall be governed by the order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
person who operates a CL without securing the necessary DOH – PTC and
corresponding DOH – LTO shall be issued a Cease–and–Desist Order (CDO) and
shall pay the administrative penalty of fifty thousand pesos (Php 50,000.00).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Section
4 of Republic Act No. 4688 shall still be impossible aside from the
administrative penalty provided in this order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
case of complaints, the CL, upon receipt of such HFSRB/CHD – RLED shall be
given due process wherein an investigation shall be conducted and the
appropriate sanctions for its violation/s. A 60–day preventive suspension may
be given go the CL during the investigation depending on the seriousness of the
violation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
CL or any of its personnel not amenable with the decision of the HFSRB/CHD –
RLED may, within ten (10) days after the receipt of notice of decision, file a
notice of appeal to the Head of the Health Regulation Team (HRT). All pertinent
documents and records of the appellant shall then be elevated by HFSRB/CHD –
RLED to the HRT. The decision of the Head of the HRT, if still contested may be
brought on a final appeal to the Secretary of Health, whose decision shall be
final and executory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">CL
with revoked licenses can only re–apply after one year from the date of LTO
revocation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l5 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Any
person authorized or licensed to conduct clinical laboratory tests, who issues
false or fraudulent laboratory test results knowingly, wilfully or through
gross negligence shall not be allowed to own, manage, operate, or be an analyst
of any DOH–licensed CL. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">X.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">TRANSITORY
PROVISIONS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l7 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">All
existing licensed shall be given three (3) years to comply with the physical plant
requirements from the date of effectivity of this order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l7 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
existing licensed CL shall be given two (2) years to fully offer the additional
services for each category with corresponding personnel and equipment from the
date of effectivity of this order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l7 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">For
New CL, this order shall be immediately applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l7 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">For
CL currently headed by Anatomic Pathologists with an associate Clinical
Pathologists or Clinical Pathologists heading tertiary CL with Anatomic
Pathology services, such as headships shall be retained until his/her eventual
retirement, resignation, or replacement. Thereafter, all CL shall be headed by
a Pathologist certified in Clinical Pathology by the Board of Pathology of the
Philippine Society of Pathologists, except for tertiary CL with anatomic
pathology service which shall be headed by a Pathologist certified in both
Anatomic and Clinical Pathology. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">XI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REPEALING CLAUSE</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">These rules and regulations shall
rescind Administrative Order No. 2007 – 0027 titled “Revised Rules and
Regulations Governing the Licensure and Regulation of Clinical Laboratories in
the Philippines,” all administrative order and previous issuances inconsistent
thereof.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">XII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SEPARABILITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">If any provision or part of this order
be declared unauthorized or rendered invalid by any court of law or competent
authority, those provisions not affected by such declaration shall remain valid
and effective. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l19 level1 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">XIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">EFFECTIVITY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">This order shall take effect fifteen
(15) days following its publication in a newspaper of general circulation and
upon filing three (3) copies to the University of the Philippines Law Center.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">FRANCISCO
T. DUQUE III, M.D., MSc.<o:p></o:p></span></span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Secretary
of Health</span></b><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr>
<td colspan="2" style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">TABLE OF ANNEXES<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Administrative Order No. 2021 – 0037 </span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" valign="top" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX NO.<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" width="526">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">CONTENT<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" valign="top" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">A<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Licensing
Standards for Clinical Laboratory<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">B1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Assessment
Tool for Licensing A General Clinical Laboratory<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">B2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Equipment/Instruments/Glassware/Supplies/Reagents
per Area of Activity / Service Capability of General Clinical Laboratory<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">C<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Prohibited
Acts in the Operations of Clinical Laboratories <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">D1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Planning and
Design Guidelines for General Clinical Laboratory<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">D2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Checklist for
Review of Floor Plans for General Clinical Laboratory<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">D3a<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Sample Floor
Plan for General Clinical Laboratory 1<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">D3b<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Sample Floor
Plan for General Clinical Laboratory 2<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">D3c<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Sample Floor
Plan for General Clinical Laboratory 3<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">E<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Guidelines in
Securing for Remote Collection Permit for Clinical Laboratories <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">F<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 394.35pt;" valign="top" width="526">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Application
Form for Certificate of Registration for Research and Teaching Clinical
Laboratory<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX A<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">LICENSING STANDARDS FOR CLINICAL LABORATORY</span></span></b></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">I.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">PHYSICAL PLANT</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
Clinical Laboratory (CL) shall have an adequate space for its operation to
provide services safely, effectively, and efficiently to clients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The CL shall conform to all
applicable local and national regulations for the construction, renovation,
maintenance, and repair of CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The laboratory shall conform to
the required space for the conduct of its activities. Personnel, fixtures,
equipment, sink, etc. shall also be considered. Minimum area requirements for
each are listed in Annex D.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">There shall be well–ventilated,
lighted, clean, safe, and functional areas based on the services provided.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a program of
proper maintenance and monitoring of physical plant and facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be policy guidelines
on laboratory biosafety and biosecurity which includes risk assessment that
will serve as the basis of biosafety level required for the specific CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be an area for
confirmatory testing for Rapid HIV Diagnostic Algorithm (CrCL) and Glucose–6–Phosphate
Dehydrogenase (G6PD) Deficiency which may be a section, unit, or division
integrated in a DOH licensed CL, if applicable. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">II.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">PERSONNEL</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
CL shall have an adequate number of trained personnel, depending on the Workload,
to provide safe, effective, and efficient services to clients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 49.8pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Head of the
Laboratory (HOL)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l12 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The head of the laboratory shall
be a competent and experienced professional, with a specialized skill set
related to and appropriate to the laboratory category, to ensure that the laboratory
staff runs efficiently. The head of the laboratory is essentially responsible
for the operation of the entire laboratory, its personnel, functions, and data,
all of which shall meet the quality assurance criteria and regulatory
requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l12 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The head of the laboratory shall
oversee the operation of the CL and have administrative and technical
supervision of the activities including the Mobile Clinical Laboratories (MCL),
remote collection activities, and Point Of Care Testing (POCT), if applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l12 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The head of the laboratory shall
supervise the staff in accordance with the standards set by the Philippine
Society of Pathologists.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l12 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The head of the laboratory shall
visit once a month and at least twice a week of supervisory calls and/or
videoconferencing OR at least once a week physical visit. For hospital–based
DOH licensed CL, it shall be once a week physical visit. The visits shall have
to be well documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l12 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">For Geographically Isolated and
Disadvantaged Areas (GIDAs) with no Clinical Pathologists, as certified by the
Philippine Society of Pathologists, board certified Anatomic Pathologists or
Physicians with complete training in Clinical Laboratory Medicine, Quality
Assurance and Laboratory Management, may head one primary DOH licensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 49.8pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Registered
Medical Technologist (RMT)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l23 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be an adequate number
of full–time RMT to conduct the laboratory procedures, including those assigned
in MCL. The number of staff shall depend on the workload and the services being
provided.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l23 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be staff development
and continuing education program at all levels of organization to upgrade the
knowledge, attitude, and skill of staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l23 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a designated
Biosafety and Biosecurity Officer in–charge primarily of the risk assessment of
the DOH licensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 49.8pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Support Staff</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l34 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be an adequate number
of support staff such as, but not limited to laboratory technician, laboratory
aide, encoders, and receptionists when applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 49.8pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">POCT Coordinator
– if applicable</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l26 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">A Senior Staff form the CL shall
be designated as POCT coordinator who shall have the following function, but
not limited to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l15 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Recommends procedures that will
ensure the quality of results of POCT in consultation with the Pathologist.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l15 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Ensures that POCT machines/device
and kits are properly maintained.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l15 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Supervises the operators of POCT
device/machine.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l15 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Ensures that the operators have
appropriate training and checks the competency of the operators regularly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l15 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Ensures that Quality Control (QC)
is implemented and reviews POCT QC results periodically, depending on the
number of tests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 49.8pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">POCT Operator –
if applicable</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l6 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The designated operator of the
POCT device/ machine and testing kits shall have the following functions, but
not limited to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l25 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Ensures accurate results of POCT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l25 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Ensure that POCT machines/device
and kits are properly maintained and stored.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l25 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Run tests on quality control at
least once each day or as recommended by the manufacturer.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l25 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Initially, implements quality
assurance program or contact the manufacturer’s Applications Specialist for
assistance, when a POCT machine/device is not properly functioning, or the
control sample is in out control range.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l25 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Reports to the supervising CL any
untoward incidents or problems concerning POCT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 49.8pt; mso-list: l1 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">MCL Personnel</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 67.8pt; mso-list: l8 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">MCL shall has it own set of
personnel, which includes the following but not limited to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l2 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Registered Medical Technologist –
number will depend on the anticipated workload.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 85.8pt; mso-list: l2 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Support staff such as, but not
limited to, driver and laboratory technician. <o:p></o:p></span></span></p>
<p class="MsoListParagraph"><span style="font-family: "Palatino Linotype", serif; line-height: 107%;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">III.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">EQUIPMENT/INSTRUMENTS/REAGENTS/GLASSWARES/SUPPLIES</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
CL shall have an adequate equipment, instruments, reagents, glassware, and supplies
which are all in good working condition and sufficient for the operations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">There shall be available and
operational equipment/machines/devices to provide the laboratory examination
that the laboratory is licensed for.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a calibration,
preventive maintenance, and repair program for every
equipment/machines/instruments/device in the DOH licensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a contingency plan
in case of equipment/machines/devices breakdown and malfunction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">There shall be adequate available
reagents, glassware, and supplies for the laboratory examinations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be an inventory
control of the reagents, glassware, and supplies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The reagents, glassware and
supplies shall be properly stored under the required conditions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">G.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The machines/devices, reagents
and test kits that are used in the CL and MCL as well as POCT shall be approved
by the Philippine Food and Drug Administration and validated by the proper
government institutions (e.g., National Reference Laboratory).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l30 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">H.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The MCL shall have its own set of
functional, and operational equipment, as well as its own set of supplies. <o:p></o:p></span></span></p>
<p class="MsoListParagraph"><span style="font-family: "Palatino Linotype", serif; line-height: 107%;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">IV.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">SERVICE DELIVERY</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
service provided by the CL shall ensure quality and safety to clients, to its personnel
and to the public.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l4 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">All Cl shall ensure that the
service being delivered to patients must comply with the standards and other
related relevant issuances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l4 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Mobile Clinical Laboratory</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 63pt; mso-list: l19 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The collection site/area for MCL
shall be located within the same region, at a maximum of one hundred (100)
kilometer radius, from the address of the DOH licensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 63pt; mso-list: l19 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Aside from specimen collection
for different tests within the service capability of the main CL, the MCL shall
be allowed to perform the following on–site tests which shall be declared in
the LTO of the main CL:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 81pt; mso-list: l29 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Urinalysis <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 81pt; mso-list: l29 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Fecalysis <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 81pt; mso-list: l29 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Pregnancy Test (lateral flow) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 81pt; mso-list: l29 level1 lfo15; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Basic Serologic Test using Rapid
Test Kits – Dengue, Screening of Hepatitis B, RPR/Syphilis Test, and HIV.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 63pt; mso-list: l19 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Specimen collected for other
test, not mentioned above (Section IV.B.2), should be properly handled and
transported. Serum blood samples for chemistry testing must be separated within
four (4) hours from the time of collection. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">V.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">INFORMATION
MANAGEMENT</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
CL shall maintain a system of communication, recording, reporting and releasing of results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Administrative
Policies and Procedures</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The CL shall have written
policies and procedures for the provision of laboratory services, the operation
and maintenance of the CL, which includes satellite laboratories, MCL and POCT,
and shall include the accountabilities of every personnel working in the
laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be documented
technical procedures for services provided in each section of the laboratory,
including MCL and POCT, which will ensure the quality of laboratory results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l27 level1 lfo17; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a risk assessment
for every section in the CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l22 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Communication
and Records Management</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The CL shall maintain and ensure
the confidentiality of all records.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be procedures for the
receipt and performance of routine and STAT requests for laboratory
examinations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be procedures for the
reporting of results of routing and STAT laboratory examinations, including
critical values that would impact on patient care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">All results shall be released in
accordance with DOH guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">All laboratory reports on various
examinations of specimens shall bear the name, PRC registration number, and original
signature of the Registered Medical Technologist(s) who performed the
laboratory examinations, and the Pathologist who shall be accountable for the
reliability of the results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a policy guideline
on the use of digital signature. The use of digital signature for laboratory
results shall be permitted only if properly authenticated by the Department of
Information and Communication – Philippine National Public Key Infrastructure.
The use of digital signature shall also be in accordance with the provisions of
the E–Commerce Law.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be procedures for the
reporting of workload, quality control, inventory control, work schedule and
assignments.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be procedures for the
reporting and analysis of incidents, adverse events, and in handling
complaints.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The retention of laboratory
documents, records, slides, and specimens shall be in accordance with the
standards promulgated by the DOH or by competent authorities for such purposes.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
operating hours of the CL shall be known to its clients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l3 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
CL which supervises the POCT shall have a master list of the following, but not
limited to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 78.6pt; mso-list: l18 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Name and designation of
operators, and, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 78.6pt; mso-list: l18 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">POCT machines, instruments, and
kits. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 42.6pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">VI.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">QUALITY
IMPROVEMENT</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
CL shall establish and maintain a system for continuous quality improvement activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l13 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be an Internal
Quality Assurance Program which shall include:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60.6pt; mso-list: l24 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">An Internal Quality Control
Program for technical procedures.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60.6pt; mso-list: l24 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">An Internal Quality Assurance
Program for inputs, processes, and outputs. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60.6pt; mso-list: l24 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">A Continuous Quality Improvement
Program covering all aspects of laboratory performance.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l13 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The CL shall participate in
External Quality Assessment Program (EQAP) that may be administered by a
designated NRL or other local and international EQAP approved by the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l13 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A periodic assessment shall be
conducted by representative from the top management, clinical laboratory,
clinical departments, and nursing service, to evaluate the policy of the CL on
POCT.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 42.6pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">VII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">REFERRAL OF
LABORATORY EXAMINATIONS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
CL shall ensure that the quality of services provided through an agreement, or
its equivalent, to a DOH licensed CL performing the laboratory services needed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l21 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The referral laboratory must be a
DOH–licensed CL. They shall have a Memorandum of Agreement (MOA) with the
referring CL and shall be responsible for the collection, transport, and
processing of specimens, and releasing of results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l21 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">A separate MOA is required when
referred tests, which are not within the service capability of the CL, unless
the referral is part of the contingency plan.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l21 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">A MOA prescribing the
accountabilities of each party, shall be secured when laboratory examinations
are referred to and provided by another DOH–licensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l21 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Referral of examinations to other
DOH–licensed Cl are only permitted in the following circumstances:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60.6pt; mso-list: l10 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">If the laboratory test to be sent
out is not part of the service capability expected for the category of the
referring laboratory; and,</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60.6pt; mso-list: l10 level1 lfo23; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">If referral of laboratory test is
part of the contingency plan, in cases of equipment breakdown, of the referring
CL, this shall be for a certain limited period only, which shall not last for
more than 3 months. This shall be properly documented. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l20 level1 lfo35; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">VIII.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">ENVIRONMENTAL
MANAGEMENT</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Every
CL shall ensure that the environment is safe for its patients and staff, including the public.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l28 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a program of
proper maintenance and monitoring of physical facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l28 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be procedures for
proper disposal of infectious wastes and toxic and hazardous substances in
accordance with R.A. 6969, also known as “Toxic Substances and Hazardous and
Nuclear Wastes Control Act of 1990” and other related policy guidelines and/or
issuances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l28 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a “No smoking
policy” and that the same shall be strictly enforced.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l28 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">D.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a contingency plan
in case of accidents and emergencies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l28 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">E.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be a policy for
biosafety and biosecurity.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l28 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">F.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">There shall be policy guidelines
on infection prevention and control. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX C<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">PROHIBITED ACTS IN THE OPERATIONS OF CLINICAL
LABORATORIES</span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Sanctions and
penalties will be based on Section IX.B of the Administrative Order</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l17 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The Clinical Laboratory (CL) may
be sanctioned or penalized upon commission of the following prohibited acts and
violations:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Refusal to allow HFSRB/CHD – RLED
authorized personnel to conduct inspection or monitoring visits of the clinical
laboratory at any appropriate time.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Refusal or non–participation of
any CL in an External Quality Assessment Program (EQAP) provided by a
designated NRL or other local and international EQAP approved by the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Absence of action to improve the
unsatisfactory or failed EQAP administered by a designated NRL or other local
and international EQAP approved by the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Demonstrating incompetence or
making consistent error in the performance of CL examinations and procedures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Deviation from the standard test
procedures including use of expired reagents.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Issuance of a laboratory report
without the approval of the head of the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Transferring of laboratory
results done by another laboratory to the result form of the referring
laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Performing laboratory procedures
beyond their authorized service capability; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Giving and receiving any
commission, bonus, kickback, or rebate or engaging in any split–free
arrangement in any form whatsoever with any facility, physician, organization,
agency or person, either directly or indirectly, for patients referred to a CL
licensed by the DOH.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l0 level1 lfo26; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Violation
of provisions in the Republic Act No. 10173 or the Data Privacy Act of 2021.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l17 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The DOH LTO will be revoked
immediately after commission of the following prohibited acts and violations:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Permitting unauthorized or
unregistered personnel to perform technical procedures and access to laboratory
records/data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Lending or using the name of the
DOH–licensed CL or head of the laboratory or Medical Technologist to an
unlicensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Unauthorized use of the name and
signature of the pathologist and RMT to secure LTO.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Issuance of fraudulent laboratory
results, or tests not actually done or inaccurate results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Change in the ownership,
location, and head of the laboratory of laboratory personnel without informing
the HFSRB/CHD – RLED and,</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo27; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Any material false statement in
the application of LTO.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l17 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">C.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Other violations similar or
analogous to the above will be sanctioned and penalized accordingly.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX D1<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">PLANNING AND DESIGN GUIDELINES FOR GENERAL CLINICAL
LABORATORY<o:p></o:p></span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l32 level1 lfo28; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">A.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;">
</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">GENERAL
CONSIDERATIONS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l31 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Location</span></b><span style="font-family: "Palatino Linotype", serif;">. The clinical laboratory shall be situated in an
area that is accessible both to clients and staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l31 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Privacy.</span></b><span style="font-family: "Palatino Linotype", serif;"> The design shall also provide appropriate levels of
the client audible and visual privacy and dignity throughout the diagnosis
process, from specimen collection to the releasing of results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l31 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Conformance with
Building Laws.</span></b><span style="font-family: "Palatino Linotype", serif;"> The clinical
laboratory shall conform to all applicable local and national regulation for
the planning and design, construction, renovation, maintenance, and repair of
its facilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l31 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Ventilation.</span></b><span style="font-family: "Palatino Linotype", serif;"> Adequate ventilation with the acceptable air
changes per hour shall be maintained for each specific area of the clinical
laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l31 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Spaced required.</span></b><span style="font-family: "Palatino Linotype", serif;"> The clinical laboratory shall have adequate space
or area provided for its various space/room requirements to attain the
effective and efficient operation of its activities and functions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.1<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
spaces/areas of the clinical laboratory shall be zoned into the following
areas, if applicable, and planned based on the functionality of the space and
the activity workflow of the laboratory:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.1.1<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">General Administrative Services
and Public Areas;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.1.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Clinical Working Area;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.1.3<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Support Services Area;</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">The
General Administrative and Public Areas</span></b><span style="font-family: "Palatino Linotype", serif;"> shall be comprised of the following spaces:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2.1<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Business Area, provided with:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 144pt; mso-list: l12 level4 lfo3; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2.1.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A Reception Area, for information
and business transactions, receiving of specimen and releasing of results.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 144pt; mso-list: l12 level4 lfo3; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2.1.3<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Sufficient waiting area for
clients.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Collection Area. There shall be a
collection area/s for specimen which is located outside the clinical working
area.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2.3<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> T</span></span><span style="font-family: "Palatino Linotype", serif;">oilet Facilities, may be withing
the premises of the facility but shall not within the clinical working area, or
may be adjacent to the clinical laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 144pt; mso-list: l31 level5 lfo29; text-indent: -54pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2.3.1.1<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Conveniently accessible toilet
for the public.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 144pt; mso-list: l31 level5 lfo29; text-indent: -54pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.2.3.1.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">A separate toilet for the staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.3<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">The
Clinical Working Area.</span></b><span style="font-family: "Palatino Linotype", serif;"> The clinical
working area shall be sufficient to accommodate its activities and allow for
smooth and coordinated workflow. Areas and rooms intended for its sections
shall be planned to meet the workload described in the functional program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.4<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">The
Support Services Area(s)</span></b><span style="font-family: "Palatino Linotype", serif;"> shall be
composed of the following spaces:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.4.1<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Sufficient storage for records
and supplies<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.4.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Sterilization area/room<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.4.3<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Waste holding area <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.4.4<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Staff pantry <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l31 level3 lfo29; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.4.5<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Other spaces for staff such as
offices, conference room, lockers and changing room (gender–sensitive) and the
like, are optional.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.5<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Business
area and support services areas</span></b><span style="font-family: "Palatino Linotype", serif;">
may be optional for One Stop Shop (OSS) Facility, provided it is identified and
accessible from the clinical laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l31 level1 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Functional and
Planning Considerations</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.1<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
different areas of the clinical laboratory shall be planned functionally
related to each other to attain efficient workflow.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
clinical laboratory shall have space allocated for the performance of its work,
and is designed to ensure the quality, safety and efficiency of the service
provided to the user and the health, safety and comfort of laboratory
personnel, patients, and visitors. The laboratory shall evaluate and determine
the sufficiency and adequacy of the space allocate for the performance of the
work to accommodate its activities and allow for smooth and coordinated workflow.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.3<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">There
shall be sufficient and appropriate storage spaces and conditions provided for
laboratory specimens, documents, records, manuals, equipment, reagents,
supplies, slides, and tissues blocks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level2 lfo29; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.4<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
clinical working area shall be sufficient to accommodate its activities and
allow for smooth and coordinated workflow. Areas and rooms intended for its
sections shall be planned to meet the workload described in the functional
program. A dedicated room or area for each section of the laboratory shall be
provided inside the clinical working area. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l32 level1 lfo28; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">B.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">SPECIFIC
TECHNICAL REQUIREMENTS</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Collection area for blood
extraction shall provide space, equipment, and furniture appropriate for its
activity performed. The area shall have work counter/tray, space for patient
seating, and handwashing stations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Specimen collection toilet for
urine and feces shall be equipped with water closet and/or urinal and lavatory.
This facility may be located outside the main clinical laboratory, a designated
cubicle for specimen collection in a toilet facility, or a dedicated toilet
solely for specimen collection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">A Pathologist’s area may be
provided and shall be located adjacent to or within the clinical working area
so that he/she may have easy access to clinical working area of the laboratory.
Its location shall permit the Pathologist to observe the clinical working area.
It can be a separate room or a cubicle within the clinical working area.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Entrance to clinical working area
must not be directly located to high traffic areas that might cause unwanted
air current drafts which may cause potential damage to equipment and possible
contamination of specimen. A hand washing area (with designated dressing area
is recommended) at the entry and exit points of the clinical working area is
required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Sections of the clinical
laboratory shall be provided with stainless steel sink with a depth of at least
8 inches and gooseneck faucet.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Each section of the laboratory
shall be properly identified in the clinical working area. Separate rooms for
both Histopathology and Microbiology section and for molecular pathology, if
provided, shall be provided.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Provision of toilets and other
amenities for staff (e.g., lockers, pantry and changing room) shall be located
outside the clinical working are to prevent contamination.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Biosafety Cabinets and isolation
hoods shall be located so that fluctuations in air supply and exhaust or the
operations of equipment do not alter the performance standard of the
cabinet/hood.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Fire safety. The clinical
laboratory shall conform to the applicable provisions of the 2019 Revised
Implementing Rules and Regulations (IRR) of Republic Act 9514 or the Fire Code
of the Philippines. In addition, there is no more than 23 meters of travel
distance to any exit door from any point of the clinical working area.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Corridors.
The minimum width for corridor for clinical laboratory shall be at least but
not limited to 1.2 meters or four (4) feet. Wider corridors shall be provided
taking into consideration of passage of large equipment, movement of people and
the activity involved.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Clearances.
Adequate clearances intended for working space in the clinical working area
shall be provided. Clearance from work counter in the clinical working area
from a wall shall be at least 1.2 meters or four (4) feet and 1.52 meters or
five (5) feet for a work counter to another work counter to allow passage of
staff while others are working. Other consideration shall also be given for
adequate clearances, such as size and type of equipment, activity involved,
ergonomics and anthropometrics.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">12.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Suitable
facilities for quick drenching or flushing of the eyes and body parts shall be
provided within the clinical laboratory for immediate emergency use. Such unit
must be within 30 meters for work access, hands–free eyewash unit with hand
wash unit is preferred.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">13.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Lighting.
All areas be well–lighted by providing appropriate luminaire with no exposed or
dangling electrical wires and unwanted glare shall be avoided. Also,
convenience outlets shall be provided within the facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">14.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Ceiling
Height. Ceiling Heigh of the clinical laboratory shall conform to the
provisions of the National Building Code of the Philippines. The
floor–to–ceiling height of rooms containing biosafety cabinet and fume hoods
shall be at least 2.6 meters. For rooms containing tall and ceiling–mounted
equipment, the ceiling shall be of sufficient height to accommodate the
equipment and/or fixtures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">15.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Plumbing.
Continuous and sufficient supply of water shall be always made available in
both working and hand washing areas. Piping systems shall be kept concealed as
possible yet should be located where they be easily accessible for service and
repairs with a minimum of disruption of normal laboratory services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">16.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Ventilation.
Artificial Air Conditioning shall be provided in the clinical working area to
attain required HVAC requirements (i.e., exhaust fan, fume hood, air
conditioning). Exhaust fan shall be provided in the clinical working area and
its sections as a minimum requirement, with dedicated exhaust fan for rooms in
the Microbiology and Histopathology sections.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Exhaust
in the clinical working area shall be directed to the outside and air from
clinical working area must not be recirculated within the facility. Directional
airflow in the laboratory is recommended, wherein air should move from clean to
less clean areas, with specific exceptions, based on the functional program of
the laboratory and its sections.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">There
should be a sufficient air exchanges in the clinical working area, depending on
the use and contents of the space.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">17.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Space.
Adequate area should be provided for the people, activity, furniture, equipment,
and utility.</span></span></p>
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<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">SPACE<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">AREA IN SQUARE METER<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 414.8pt;" valign="top" width="553">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">GENERAL ADMINISTRATIVE AND PUBLIC
AREAS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Business Area<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"> </span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"> Reception Area<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">5.02 m<sup>2</sup>/staff<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"> Waiting Area<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">0.65 m<sup>2</sup>/person<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Collection
Area<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"> </span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"> Extraction Area (for blood)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">6 m<sup>2</sup>/chair
or couch<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"> Specimen Collection Toilet <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"> (for stool and urine)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">1.67 m<sup>2</sup><o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Public Toilet<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">3.06 m<sup>2</sup><o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Staff Toilet<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">1.67 m<sup>2</sup><o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Pathologist
Area<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">5.02 m<sup>2</sup>/staff<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 414.8pt;" valign="top" width="553">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">SUPPORT SERVICES AREA<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Storage Area
for Supply and Records<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">4.65 m<sup>2</sup>
or 1.2 m<sup>2</sup>/storage unit<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Sterilization
Unit/Room<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">4.65 m<sup>2</sup><o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Waste Holding
Area<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">4.65 m<sup>2</sup><o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Staff Pantry<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">1.4 m<sup>2</sup>/person<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 254.35pt;" valign="top" width="339">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Conference
Room (Optional)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 160.45pt;" valign="top" width="214">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">1.4 m<sup>2</sup>/person<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">18.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Material
Specification</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt; mso-list: l9 level2 lfo30; text-indent: -24pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">18.1<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Walls
and partition. All walls of the Clinical Laboratory in general shall be
structurally sound, safe, and sturdy with minimum fire–resistant rating as
prescribed by the Fire Code of the Philippines for this type of occupancy. Wall
finish shall be with impervious, smooth, less terminations, and easy to clean. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Interior
wall or partitions and walls of the clinical working area and its sections
shall be constructed from floor to ceiling.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Cubicle
curtains and draperies if used for the clinical laboratory shall be non–
combustible or flame–retardant.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt; mso-list: l9 level2 lfo30; text-indent: -24pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">18.2<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Flooring.
Floors in general shall be made of durable and shall be readily cleanable and wear
resistant. Floor subject to traffic while wet (i.e., entrance porch, toilet
facilities) shall have a non–slip surface. Floors in the clinical working area
shall be seamless and self–coving to a height of 6 inches (152.4 mm) towards
the wall.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt; mso-list: l9 level2 lfo30; text-indent: -24pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">18.3<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Work
counters. Work counters shall be provided with finish that does not support
bacterial growth, durable, non–porous, smooth, and easy to clean, stain and
dirt resistant, preferably seamless finish. Sink or lavatory, preferably
stainless steel with faucet, preferably gooseneck, with adequate supply of
water shall be provided. The width of the work counter shall be at least 600 mm
(750 mm or 30 inches is preferred).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Backsplash
or wainscoting shall be provided in the work counter, preferably with the same
material with the countertop finish or its equivalent with at least 400 mm
high.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt; mso-list: l9 level2 lfo30; text-indent: -24pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">18.4<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Windows.
Windows and openings shall follow the requirements of Rule VII of the National
Building Code of the Philippines. If operable window is utilized in the
clinical working area, it should be fitted with arthropod–proof screens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt; mso-list: l9 level2 lfo30; text-indent: -24pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">18.5<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Doors.
The minimum clear opening for the main door/s of the clinical laboratory and
the clinical working area and exit doors shall be at least 900mm. There shall
also be at least one door with a minimum width of 900mm for rooms/sections
housing large instruments and equipment. No doors in the clinical working area
shall be less than 800mm. The main door of the clinical laboratory and doors to
the clinical working area shall have appropriate fire ratings, and preferably
be self-closing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 60pt; mso-list: l9 level2 lfo30; text-indent: -24pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">18.6<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Carpeting,
fabrics, wood, and other similar finishes shall be avoided.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l9 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">19.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Additional
Requirements</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
clinical laboratory shall provide for additional requirements depending on the
type of pathogens handled in the facility and biosafety level required based on
the conducted risk assessment, in adherence with the requirements of laboratory
biosafety and biosecurity.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"> </span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">ANNEX E<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">GUIDELINES IN SECURING FOR REMOTE COLLECTION PERMIT
FOR CLINICAL LABORATORIES</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Only DOH–licensed Clinical
Laboratories (CL) without mobile clinical laboratory (MCL) shall be required to
apply for Remote Collection Permit – CL (RCP – CL).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Remote collection can only be
done in the following non–clinical laboratory settings such as but not limited
to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l14 level2 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.1.</span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Schools <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l14 level2 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.2.</span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Offices <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l14 level2 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.3.</span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Churches <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l14 level2 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">2.4.</span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Other areas used
for community–based activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The remote collection facility
should have a proper area for specimen collection (e.g., clean toilet for urine
and stool collection).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Only employed Registered Medical
Technologists (RMTs) of the applicant’s CL shall be allowed to collect blood
samples/specimens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The activity at the remoted
collection facility shall only last for four (4) to six (6) hours.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">No testing at the remote
collection facility shall only last for four (4) to six (6) hours.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">7.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Specimen should be properly
handled and transported.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l7 level1 lfo32; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Samples for routine urinalysis
and routine fecalysis shall be stored at refrigerated temperature within one
(1) hour from the time of collection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l7 level1 lfo32; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The serum from blood samples for
chemistry must be separated within four (4) hours from the time collection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">8.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">The remote collection facility
shall be located within the same region, at a maximum of one hundred (100)
kilometer radius, from the address of DOH licensed CL.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">9.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">RCP – CL shall be secured from
the DOH at least seven (7) working days prior to the scheduled activity.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">10.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">RCP
– CL shall be secured from the DOH regulatory office in accordance with DOH
guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">11.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">RCP
– CL shall be signed by the Director IV of HRSRB or Center for Health
Development (CHD), or his designate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">12.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
following are the documentary requirements:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l11 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Letter of request, signed by the
Head of Clinical Laboratory, to conduct remote collection with the following
information:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l33 level1 lfo34; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Name
of the Facility with DOH – LTO number <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l33 level1 lfo34; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Address
of facility <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l33 level1 lfo34; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Date
of collection <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l33 level1 lfo34; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Time
of collection <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l33 level1 lfo34; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Venue
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l33 level1 lfo34; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Estimated
number of clients <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l33 level1 lfo34; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: Symbol;">·<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Specimen
to be collected.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l11 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Notarized Memorandum of Agreement
or contract between the contracting parties.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l11 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">Technical or operational
procedures for remote collection including specimen handling and transportation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l11 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><span style="font-family: "Palatino Linotype", serif;">List of laboratory
supplies/equipment to be used during remote collection including the transport
materials.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">13.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
remote collection permit fee of Php 500.00 for each site shall be collected
from the clinical laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">14.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
RCP – CL shall be valid only up to the date of collection. In case of failure
to conduct the collection at the specified date, the laboratory shall inform
the HFSRB or CHD – Regulation, Licensing and Enforcement Division (CHD – RLED)
in writing, at least within 48 hours before the scheduled date of remote
collection and shall be informed of the new schedule which should be within the
validity period. Otherwise, another RCP – CL shall be secured.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">15.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
copy of the RCP – CL shall be posted in conspicuous area of the remote
collection facility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">16.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
clinical laboratory shall maintain records of all remote collection performed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">17.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
HFSRB or CHD – RLED may inspect the remote collection site prior to the
issuance of the permit or monitor during the actual collection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">18.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">In
case of failure to conduct the collection at the specified date, the laboratory
shall inform the HFSRB or CHD – RLED in writing, at least within 48 hours
before the scheduled date of remote collection and shall be informed of the new
schedule which should be within the validity period. Otherwise, RCP – CL shall
be secured.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">19.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Home
service blood collection shall be exempted from securing RCP – CL provided,
that it is upon the patient’s doctor request, and the area of collection must
be within (1) hour travel time, under normal circumstances, from the licensed
clinical laboratory. To ensure proper specimen collection and handling,
provision nos. 4, 5, 7.1 and 8 of these guidelines should be followed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">20.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-variation-settings: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Violations
of the guidelines stated herein, and related policies of laws shall be the
basis for suspension/revocation of the RCP – CL and the LTO of the main
clinical laboratory. </span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l14 level1 lfo31; text-indent: -18pt;"><span style="color: #01ffff; font-size: large;"></span></p><div class="separator" style="clear: both; text-align: center;"><span style="color: #01ffff; font-size: large;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiZaB-fr49GfIPeVM3UzxuTvnK8gcU_PVS9iUTU9E8V-s5Xt-tjjnsxC7_AKyABNQzRzIoIhycJOsyGXnjefe2IcdsRjgoT-1i2eOQWX0TsOqfZOY1_DzEtbbc0A-sVkHa7eDT5EKl39qKZ8zMHj7q_efBSomtaIP3VnG7KN-AL00dWCnNAo-KPWvD2qYI/s165/Microscope2.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" data-original-height="165" data-original-width="159" height="165" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiZaB-fr49GfIPeVM3UzxuTvnK8gcU_PVS9iUTU9E8V-s5Xt-tjjnsxC7_AKyABNQzRzIoIhycJOsyGXnjefe2IcdsRjgoT-1i2eOQWX0TsOqfZOY1_DzEtbbc0A-sVkHa7eDT5EKl39qKZ8zMHj7q_efBSomtaIP3VnG7KN-AL00dWCnNAo-KPWvD2qYI/s1600/Microscope2.jpg" width="159" /></a></span></div><span style="color: #01ffff; font-size: large;"><br /><span style="font-family: "Palatino Linotype", serif;"><br /></span></span><p></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-83829923340973270432023-03-18T22:42:00.000+08:002023-03-18T22:42:15.474+08:00The HIV Virus<p><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Human
Immunodeficiency Virus (HIV) is an enveloped human retrovirus of the lentivirus
family. Two strains of HIV have been described, HIV-1 and HIV-2, the latter
found mostly in Western Africa. HIV-1 is the more virulent strain.</span></span></p><p><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff;"></span></span></p><div class="separator" style="clear: both; text-align: center;"><span style="color: #01ffff;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEggPH0rgyRrt3oBAOiervqvGbDUH8eyacwtUNPhurkrbsrBnqUYcMq8eusxVMdF7ZDH91q5RA7Zz8QJ3T6zzgKP8OYEnooT0e_qQjPb9rBdkGuKyqyTiIvLyoG09zFLPbS0hq2skvR-eSA693lwMcnJK7QsSq0Zf13sp0Du5U4y6JGgKp3CV_T8FBjc/s723/HIV%20Structure.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="585" data-original-width="723" height="518" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEggPH0rgyRrt3oBAOiervqvGbDUH8eyacwtUNPhurkrbsrBnqUYcMq8eusxVMdF7ZDH91q5RA7Zz8QJ3T6zzgKP8OYEnooT0e_qQjPb9rBdkGuKyqyTiIvLyoG09zFLPbS0hq2skvR-eSA693lwMcnJK7QsSq0Zf13sp0Du5U4y6JGgKp3CV_T8FBjc/w640-h518/HIV%20Structure.jpg" width="640" /></a></span></div><span style="color: #01ffff;"><span style="font-size: large;"><br /></span></span><p></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
viral core contains two identical single strands of genomic RNA and three
enzymes: <i>integrase, protease and reverse transcriptase</i>. The envelope,
which is derived from the host cell membrane displays viral glycoproteins,
including <i>gp120 and gp41</i>, which are critical for infection.</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"></span></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipEWyR-RX3VeCvONtWokYkMUtYO9EFqtLvc6vBkQaFdn3n9JhuBLYvQU81tN_OLUaofcjoh2JU_-Fsem1VnK94FTWDLmyy_ZAFrt9Xc7v5QPHmOOj3ZeD0TMgPZ7O2J7-H2zOCg8yu6wep9pD2gvbh8SBuNK7npxIlV0-YWCrHQ2sckARhbQTs8iMH/s800/HIV%20Penetration.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><span style="color: #01ffff;"><img border="0" data-original-height="506" data-original-width="800" height="404" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipEWyR-RX3VeCvONtWokYkMUtYO9EFqtLvc6vBkQaFdn3n9JhuBLYvQU81tN_OLUaofcjoh2JU_-Fsem1VnK94FTWDLmyy_ZAFrt9Xc7v5QPHmOOj3ZeD0TMgPZ7O2J7-H2zOCg8yu6wep9pD2gvbh8SBuNK7npxIlV0-YWCrHQ2sckARhbQTs8iMH/w640-h404/HIV%20Penetration.jpg" width="640" /></span></a></div><p></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">gp120
has high affinity for CD4, therefore cells expressing CD4, such as CD4+ T
cells, and macrophages/monocytes and dendritic cells which also express low
levels of surfaces CD4, are potential targets for the virus.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">After binding to the CD4, gp120 must
also bind a coreceptor. Two chemokine receptors can fulfil this role depending
on the tropism of the HIV. This tropism is determined by the variant of the
gp120 molecule. <i>Macrophage–tropic HIV</i> <i>uses CCR5</i> and requires only
a low level of CD4 on the host cell. CCR5 is expressed by macrophage, dendritic
cells and CD4+ T cells. <i>Lymphotropic HIV</i> <i>uses <a href="https://en.wikipedia.org/wiki/CXCR4" target="_blank">CXCR4</a></i> found on T
cells and requires a high density of CD4 on the cell surface. Both coreceptors
are G-coupled proteins with seven transmembrane spanning domains. <a href="https://en.wikipedia.org/wiki/CCR5" target="_blank">CCR5</a> normally
binds <a href="https://en.wikipedia.org/wiki/CCL5" target="_blank">RANTES</a>, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7124056/" target="_blank">MIP-1a</a> and <a href="https://www.prospecbio.com/mip-1b_human" target="_blank">MIP-1B</a>. CXCR4 binds stromal derived factor-1.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">CCR5 seems to be the major coreceptor
for establishing primary infection since individuals with mutations in CCR5
appear to be at least partially protected. Development of drugs directed at
chemokine receptors is thus an active area of research. It is suggested that if
an individual is first infected by sexual contact with a macrophage tropic
variant, the virus will be established in the mucosal associated lymphoid tissue
where macrophage and dendritic cells will then provide a reservoir. Exposure to
antigen promotes viral replication, a switch to the lymphotropic form and
further rapid dissemination in the body. The tropism of the virus changes
within the infected individual.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Following
binding of gp120 to CD4 and its coreceptor, gp41 allows fusion of the viral
envelope and cell membrane with viral entry.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">In
the host cell, viral RNA is replicated to a cDNA copy by its enzyme, <i>reverse
transcriptase</i>.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">cDNA
then enters the nucleus where it is integrated into the host genome as a
provirus with the help of the viral enzyme, <i>integrase</i>. The virus may
remain in this relatively latent form for years.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
HIV genome has a long terminal repeat region (LTR) at each end. The LTR is
required for viral integration and has binding sites for regulatory proteins.
When the T cell is activated by antigen, a cascade of reactions results in an
increase in NF-kB transcription factor. NF-kB binds to a promoter region in LTR
activating transcription of the provirus by host RNA polymerase.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
long mRNA transcript is spliced at alternative sites for protein synthesis. The
first two proteins made are Tat and Rev. Tat returns to the nucleus, acting as
a transcription factor itself, binding to LTR and increasing the rate of viral
transcription. Rev also acts in the nucleus, binding to the Rev responsive
element in the viral mRNA transcript and increasing RNA transport rate to the
cytoplasm. When the mRNA is transported more rapidly, less splicing occurs in
the nucleus. Thus, the second wave of proteins made are structural components
of the viral core and envelope. In the third wave, unspliced RNA serves as the
RNA for the new viral particles and for the translation of gag and pol. Pol
codes for the viral protease, which cleaves the product of env to produce gp120
and gp41, reverse transcriptase, and integrase.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Release
of virus from CD4+ T cells frequently results in lysis of the cell, whereas the
macrophage serves as a reservoir, transporting virus to other parts of the body
(lymphoid tissue and central nervous system) and producing a small number of
particles without cytopathic consequences.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Azidothymidine
(AZT), also called Zidovudin, is an inhibitor of reverse transcriptase and was
the first promising drug used in HIV infection. Protease inhibitors form a
second class of agents in use. HIV is capable of an amazing rate of spontaneous
mutation during the course of an infection in a single individual. This is as a
result of lack of fidelity of the reverse transcriptase and RNA polymerase. In
consequence, drug resistance develops rapidly.</span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Clinical
Course</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Acute
Infection</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Upon initial infection with HIV, many
patients are asymptomatic. Others show a flulike illness, characterized by
fever, sore throat, and general malaise starting 2 to 4 weeks after infection
and lasting 1 to 2 weeks. During this time there is viremia (virus in
peripheral blood) and a precipitous drop in circulating CD4+ T cells. The
immune system responds by generating cytotoxic T cells and antibodies specific
for the virus. the CTL are partially responsible for the drop in CD4+ T cells,
killing virally infected cells. At this point the patient has seroconverted,
expressing detectable antibody to HIV proteins. The number of CD4+ T cells in
the peripheral blood then recovers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Chronic
Latent Phase</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Although the immune response seems
standard for a viral infection, it merely contains rather than eradicates the
virus. The extremely high rate of mutations may explain the ineffectiveness of
the immune response. A latent phase is established which may last as long as 15
years.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">During this relatively asymptomatic
period, a low level of viral replication continues, associated with a gradual
decline in CD4+ T cell number. HIV, therefore, never has a truly latent phase.
The number of virally infected T cells in the peripheral blood is extremely low
during this phase. The lymph nodes are the predominant location of infected
cells. Macrophages act as reservoir. Follicular dendritic cells function not
only as reservoir but also to present virus to T and B cells, resulting in the
intense follicular (germinal center) hyperplasia and lymphadenopathy typical of
this phase.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The T cells are undergoing a slow rate
of lysis, which eventually results in involution of the lymph node. This T cell
death seems to be the result of a combination of factors. First, production of
virus in the cells themselves causes lysis. Second, the infected cell seems to
be more susceptible to apoptosis. Third, CTLs kill some of the infected cells.
Finally, uninfected T cells may be killed in an ADCC like mechanism due to
binding of soluble gp120 and anti-gp120 antibody to CD4 molecules expressed on
their surface.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Patients have traditionally been followed
during this phase by their peripheral CD4+ T cell counts and CD4/CD8 cell
ratio. The ratio, which is normally approximately 2, is reversed with CD8 cells
outnumbering CD4 cells. This can be seen in other viral infections; however, in
those cases the reversal is often due to an increase in CD8+ cells. In HIV,
CD4+ T cells are diminished. As these cells reach progressively lower values,
the patient becomes symptomatic, entering the final phase, AIDS.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><b><span style="font-family: "Palatino Linotype", serif;">Crisis
Phase</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">What initiates this symptomatic, or crisis
phase appears to be several factors acting concurrently. The gradual drop in
CD4+ T cells eventually results in an immunodeficient state, leaving the
individual susceptible to opportunistic infections, as is seen in patients with
primary immunodeficiency and in immunosuppressed transplant patients.
Activation of virally infected T cells by antigen results in stimulation of
viral transcription and pyrogeny formation. This leads to accelerated T cell
death, exacerbating the immunodeficient state. Rapid viral replication also
increases the mutation rate, allowing escape from any immune controls that
might remain.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The patterns of infection and
malignancies may partially reflect the risk factors for a particular patient.
This is suggested by differences seen between AIDS patients and other
immunosuppressed individuals and among AIDS patients with different modes of
exposures. Thus, some individuals have not only been infected with HIV but also
with other sexually transmitted diseases. Human papillomavirus (HPV) is
associate with the development of cervical cancer in women. Exposure to HPV,
combined with the individual's immunodeficient state, may be responsible for a
markedly increased incidence of invasive cervical cancer in HIV+ women. The CDC
has now included invasive cervical cancer in the AIDS-associated malignancies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The aggressive form of <a href="https://www.mayoclinic.org/diseases-conditions/kaposis-sarcoma/cdc-20387726" target="_blank">Kaposi's sarcoma</a>
(KS) is virtually unique to AIDS patients, particularly male homosexuals, in
whom it may occur early in the course of the disease. This abnormal proliferation
of small blood vessels normally presents as a slow-growing tumor on the lower
extremity skin of elderly men. Human Herpes Virus 8 (HHV-8) has been identified
in KS from AIDS patients. Whether these vessels grown in response to the virus,
or the virus is directly oncogenic is unknown. This virus is also associated
with an unusual form of aggressive lymphoma seen in AIDS patients, primary
effusion lymphoma. Again, this malignancy is more common in male homosexual
AIDS patients, and some have both the lymphoma and KS concurrently.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Aggressive B-cell lymphomas, mostly
EBV-associated, are seen at an incidence similar to that seen in
immunosuppressed transplant patients. These lymphomas are usually Burkitt's
lymphoma or diffuse large B cell and are often found outside the lymph nodes
(extranodal). In AIDS, the CNS is a frequent site of primary lymphoma.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The infectious diseases in AIDS reflect
the patient's markedly depressed cell mediated immune system. As in any T
cell-immunodeficient patient, Pneumocystis carinii pneumonia (PCP) is a major
infectious complication. <a href="https://www.webmd.com/skin-problems-and-treatments/guide/what-is-candidiasis-yeast-infection" target="_blank">Candidiasis</a> is seen relatively early in AIDS. In addition,
the B cells are chronically stimulated, resulting in polyclonal
hypergammaglobulinemia (elevated serum immunoglobulins), circulating immune
complexes, and markedly increased plasma cell production. Despite this apparent
B-cell activity, patients are unable to mount an effective antibody response to
new antigens, perhaps due to the T-cell defect, however they also have difficulty
with encapsulated organisms. Normally not a human pathogen, Mycobacterium avian
can cause overwhelming infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The CNS is infected with HIV presumably
via transport by macrophage. The virus infects microglia cells, which are of
the macrophage lineage, oligodendrocytes, and astrocytes. The CNS is
susceptible to infection by cryptococcus, toxoplasmosis and CMV. In addition, AIDS-related
dementia and progressive encephalopathy has been frequently documented. In
total, up to 50% of AIDS patients show CNS symptoms and over 70% have CNS
changes at autopsy.</span></span></p><p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Prevention
and Control</span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">HIV
is best accomplished by avoiding unprotected contact with blood and body fluids
from infected individuals. Education and public awareness of both what to avoid
and what is safe (casual contact) is required to control the disease and
contain possible panic.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">HIV+
pregnant women are placed on AZT to decrease viral load and thereby diminish
risk of placental virus transfer. Caesarean section is performed to eliminate
infection during passage through the birth canal. finally, exposure to breast
milk is avoided.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Immediately
following accidental exposure to infected products, AZT is administered to
prevent establishment of infection.</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Diagnosis</span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">HIV
infection is generally by detection of antibodies by ELISA and confirmed by
Western blot analysis. Patients have been monitored by following their absolute
CD4+ T-cell count in the peripheral blood. Correlations have shown that
opportunistic infections generally are not seen with CD4 counts above 500/ul.
The CDC has designated CD4 counts below 200/ul as an indicator of full-blown
AIDS.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><a href="https://www.fhi360.org/sites/default/files/media/documents/linkages-tld-transition-information.pdf" target="_blank">Therapy</a>
with AZT has been used for individuals whose CD4 counts were decreasing below
the 500 marks. Currently, individuals who are HIV-positive, but asymptomatic,
are placed on triple-agent antiviral therapy with inhibitors directed against
reverse transcriptase, protease and nucleoside. This therapy prevents infection
of new cells; however, infected cells remain until lysed. Patients are now
monitored for viral load by quantitative analysis of viral RNA following PCR.
The fall in viral titers is rapid and dramatic, but a small baseline titer
almost always remains. Discontinuation of the drugs results in a resurgence of
virus as one would expect. Unfortunately, mutations allow escape from control
by these agents, thus the push to develop an extensive armory of drugs. The
therapy is not without side effects, particularly suppression of hematopoietic
cells. Additional time is needed to see how successful this approach will be.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">HIV
presents a serious challenge to vaccine development. The ability of the virus
to escape eradication despite both an antibody and cytotoxic T-cell response in
recently infected individuals is evident. both the virus' ability to hide out
and its high mutation rate need to be overcome. The question of which arm of
the immune system (cell mediated immunity or antibody production) is desirable
has not been answered.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
greatest hope would be to have the immune response ready before exposure, as is
done in most other vaccines. However, animal models are limited, the best being
in the simian monkey, which develops a similar disease after infection with
simian immunodeficiency virus (SIV). Human testing is fraught with many ethical
difficulties. Understanding the molecular biology and structure of all viral
components will be essential for development of a safe vaccine.</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-67426974598967618032023-03-13T22:14:00.000+08:002023-03-13T22:14:56.922+08:00Biosafety Level<p><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biohazard
levels, more commonly referred to as “biological safety levels” or “biosafety
levels,” are classifications of safety precautions necessary to be applied in
the clinical microbiology laboratory depending on specific pathogens handled
when performing laboratory procedures. Developed by the Centers for Disease
Control and Prevention (CDC), this principle provides a way for medical
laboratory scientists and other lab personnel to identify and limit any
biological hazards and further reducing the risk in the laboratory. Biohazard
levels, on the other hand, also support the principle of biosecurity, which
aims at preventing the use of microorganisms as harmful biological agents.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Laboratory
associated infections continue to become sources of diseases to the laboratory
workforce; this is because of the failure in implementing fundamental control
measures in the laboratory which stems from the most effective control which is
"elimination", followed by "substitution",
"engineering controls", "administrative", and
"personal protective equipment" (e.g., respirator use) as the least
effective.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Four
classifications of biosafety levels (BSLs) exist. Each level contains specific
recommendations for a clinical microbiology laboratory with a focus on
laboratory practices, safety equipment, and facility construction. As each
level progresses, it includes additional biosafety considerations from the
previous level. For example, BSL-2 has kept the components of BSL-1 with
further requirements, and the same applies to BSL-3 (BSL-2 with additional
requirements) and BSL-4 (BSL-3 with additional requirements). The complexity of
each level aligns with infectivity, disease severity, the microorganisms’
ability for transmission (including exposure routes), and the nature of the
laboratory work to be performed.</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biosafety
Levels</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l0 level1 lfo3; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Biosafety
Level 1 (BSL-1)</span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">BSL-1 labs are used to study infectious
agents or toxins not known to consistently cause disease in healthy adults.
Microorganism in this level only pose “minimal hazards” to the laboratory and
community. They follow basic safety procedures, called Standard Microbiological
Practices, and require no special equipment or design features. Standard
engineering controls in BSL-1 laboratories include easily cleaned surfaces that
can withstand the basic chemicals used in the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biohazard Level 1 usually includes
viruses and bacteria like Escherichia coli and chickenpox and many
non-infectious bacteria. The level of precaution at this level is minimal and
usually involves wearing a face mask and no close contact.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l0 level1 lfo3; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Biosafety
Level 2 (BSL-2)</span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">BSL-2 laboratories are used to study
moderate-risk infectious agents or toxins that pose a risk if accidentally
inhaled, swallowed, or exposed to the skin. Microorganism in this level only pose
“moderate hazards” to the laboratory and community. Design requirements for
BSL-2 laboratories include hand washing sinks, eye washing stations in case of
accidents, and doors that close automatically and lock. BSL-2 labs must also
have access to equipment that can decontaminate laboratory waste, including an
incinerator, an autoclave, and/or another method, depending on the biological
risk assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biohazard Level 2 usually involves
microorganisms that are responsible for mild infections in humans and are often
difficult to contract via aerosolized particles, like hepatitis A, B, and C,
Lyme disease, Salmonella, measles, mumps, HIV, and dengue. Laboratory personnel
can carry out diagnostic tests on the specimens but need to wear gloves, facial
protection, and a gown. Additionally, standard precautions at this level should
be applied when handling clinical samples from the current outbreak
investigations of acute respiratory distress syndrome (ARDS) caused by the
Coronavirus Disease 2019 (COVID-19).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l0 level1 lfo3; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Biosafety
Level 3 (BSL-3)</span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">BSL-3 laboratories are used to study
infectious agents or toxins that may be transmitted through the air and cause
potentially lethal infection through inhalation exposure. Microorganism in this
level pose “serious hazards” to the laboratory and community. Researchers
perform all experiments in biosafety cabinets that use carefully controlled air
flow or sealed enclosures to prevent infection. BSL-3 laboratories are designed
to be easily decontaminated. These laboratories must use controlled, or
“directional,” air flow to ensure that air flows from non-laboratory areas
(such as the hallway) into laboratory areas as an additional safety measure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Other engineered safety features include
the use of two self-closing, or interlocked, doors, sealed windows, and wall
surfaces, and filtered ventilation systems. BSL-3 labs must also have access to
equipment that can decontaminate laboratory waste, including an incinerator, an
autoclave, and/or another method, depending on the biological risk assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biohazard Level 3 includes
microorganisms that can be fatal to humans but for which vaccines and other
treatments are available. Aside from Mycobacterium tuberculosis, this grouping
also includes anthrax, many types of viral encephalitis, hantavirus, Rift
valley fever, malaria, Rocky Mountain spotted fever, and yellow fever.</span></span></p>
<div style="text-align: center;"><span style="color: #01ffff;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="400" src="https://www.youtube.com/embed/z2Dka1VC2PE" title="YouTube video player" width="510"></iframe></span></div><div style="text-align: center;"><span style="color: #01ffff;"><br /></span></div><div style="text-align: center;">
<span style="color: #01ffff;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="400" src="https://www.youtube.com/embed/0tk2hlAFirA" title="YouTube video player" width="510"></iframe></span></div><p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l0 level1 lfo3; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Biosafety
Level 4 (BSL-4)</span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">BSL-4 laboratories are used to study
infectious agents or toxins that pose a high risk of aerosol-transmitted
laboratory infections and life-threatening disease for which no vaccine or
therapy is available. The laboratories incorporate all BSL 3 features and
occupy safe, isolated zones within a larger building or may be housed in a
separate, dedicated building. Access to BSL-4 laboratories is carefully
controlled and requires significant training.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biosafety level 4 (BSL-4) is the highest
and "most complex" biohazard level, involving a relatively few
clinical microbiology laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biohazard Level 4 usually includes
dangerous viruses like Ebola, Marburg virus, Lassa fever, Bolivian hemorrhagic
fever, and many other hemorrhagic viruses found in the tropics. Only specific
persons can work with these viruses, and it requires them to wear a positive
pressure personnel suit, with a segregated air supply. There is no treatment
available for these viruses, and extreme isolation precautions are mandatory.
The CDC has many recommendations on how to manage these viruses. There are no
bacteria in this group.</span></span></p>
<p class="MsoNoSpacing" style="text-indent: 18pt;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">There are two types of BSL-4
laboratories:</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l1 level1 lfo4; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><b><span style="font-family: "Palatino Linotype", serif;">Cabinet
laboratory</span></b><span style="font-family: "Palatino Linotype", serif;">
– all work with infectious agents or toxins is done in a Class III Biosafety
Cabinet with very carefully designed procedures to contain any potential
contamination. In addition, the laboratory space is designed to also prevent
contamination of other spaces.</span></span></span></p>
<div style="text-align: center;"><span style="color: #01ffff;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="400" src="https://www.youtube.com/embed/5isVPg_Sx5w" title="YouTube video player" width="510"></iframe></span></div><p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l1 level1 lfo4; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><b><span style="font-family: "Palatino Linotype", serif;">Suit
laboratory</span></b><span style="font-family: "Palatino Linotype", serif;">
– Laboratory personnel are required to wear full-body, air-supplied suits,
which are the most sophisticated type of personal protective equipment. All
personnel shower before exiting the laboratory and go through a series of
procedures designed to fully decontaminate them before leaving.</span></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
engineering controls required are different for BSL-4 cabinet and suit
laboratories. For either type, they are extensive and supplemented by carefully
designed procedures and practices.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><br /></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="5" style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">RELATION OF
RISK GROUPS TO BIOSAFETY LEVELS <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 42.3pt;" valign="top" width="56">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Risk<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Group<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 3cm;" valign="top" width="113">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biosafety<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Level<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 99.2pt;" valign="top" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Laboratory<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Type<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 106.35pt;" valign="top" width="142">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Laboratory<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Practices<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 117.9pt;" valign="top" width="157">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Safety<o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Equipment<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 42.3pt;" width="56">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 3cm;" width="113">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Basic
– Biosafety <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Level
1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 99.2pt;" width="132">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Basic
Teaching,<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Research<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 106.35pt;" width="142">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">GMT<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 117.9pt;" width="157">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">None;
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Open
Bench Work<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 42.3pt;" width="56">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 3cm;" width="113">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Basic
– Biosafety<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Level
2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 99.2pt;" width="132">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Primary
Health Services; Diagnostic Services, Research<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 106.35pt;" width="142">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">GMT
plus protective clothing,<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biohazard
Sign<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 117.9pt;" width="157">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Open
bench plus BSC for potential Aerosols <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 42.3pt;" width="56">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 3cm;" width="113">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Containment
– Biosafety <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Level
3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 99.2pt;" width="132">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Special
Diagnostic Services, Research<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 106.35pt;" width="142">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Same
as Level 2 plus special clothing, controlled access, directional airflow<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 117.9pt;" width="157">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">BSC
and/or other primary devices for all activities <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 42.3pt;" width="56">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 3cm;" width="113">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Maximum
containment – Biosafety <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Level
4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 99.2pt;" width="132">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Dangerous
pathogen units <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 106.35pt;" width="142">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Same
as Level 3 plus airlock entry, shower exit, special waste disposal<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 117.9pt;" width="157">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Class
III BSC, or positive pressure suits in conjunction with Class II BSCs,
double–ended autoclave (through the wall) filtered air<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6; mso-yfti-lastrow: yes;">
<td colspan="5" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><i><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff; font-size: large;">BSC
– Biologic Safety Cabinet<o:p></o:p></span></span></i></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><i><span style="font-family: "Palatino Linotype",serif;">GMT
– Good Microbiological Techniques</span></i><span style="font-family: "Palatino Linotype",serif;">
<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><br /></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="5" style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">SUMMARY OF
BIOSAFETY REQUIREMENTS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">4<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Isolation
of Laboratory<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Room
sealable for decontamination<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="background: rgb(217, 217, 217); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Ventilation</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Inward
Airflow<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Desirable<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Controlled
ventilation system<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Desirable<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">HEPA–filtered
air exhaust <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES/NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Double–door
entry<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Airlock
<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Airlock
with shower<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Anteroom<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">–<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Anteroom
with shower<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES/NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Effluent
Treatment<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES/NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td style="background: rgb(217, 217, 217); border-top: none; border: 1pt solid windowtext; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Autoclave</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
<td style="background: rgb(217, 217, 217); border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 217; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: large;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">On
site<o:p></o:p></span></span></p>
</td>
<td style="background: white; border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">NO</span><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></span></p>
</td>
<td style="background: white; border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">Desirable</span><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></span></p>
</td>
<td style="background: white; border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">YES</span><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></span></p>
</td>
<td style="background: white; border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-background-themecolor: background1; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: large;"><span style="font-family: "Palatino Linotype", serif;">YES</span><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In
Laboratory Room<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Desirable<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Double–ended<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Desirable<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Biologic
Safety Cabinets<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Desirable<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 226.55pt;" valign="top" width="302">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Personnel
safety Monitoring Capability <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">NO<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 2cm;" valign="top" width="76">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Desirable<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 54.15pt;" valign="top" width="72">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">YES<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table></div>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></b></p><p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Risk
Categories of Microorganisms</span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">In
both the NIH guidelines and the WHO manual, four categories of microorganisms
used in laboratory work are recognized. The basis of the classification is the
risk of infection to laboratory workers and, in the event of escape from the
laboratory to the community. Assigning a microorganism to a risk category is
dependent on an initial risk assessment made by the investigator and is based
on current knowledge of the:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Pathogenicity
of the organism (all microorganisms do not cause diseases),</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Host
range and mode of transmission of the organism,</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Local
availability of effective measures to prevent a disease outbreak, and</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo1; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Local
availability of effective treatment.</span></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
Appendix B of the NIH guidelines, Classification of Human Etiological Agents based
on Hazard, as does Table 1 of the WHO manual, recognizes four Risk Groups of
microorganisms:</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Risk
Group 1:</span></b><span style="font-family: "Palatino Linotype", serif;">
Microorganisms unlikely to cause human or animal diseases and thus pose little
or no risk to individuals and to the community; sometimes designated as <i>Generally
Regarded As Safe</i> (GRAS) organisms (e.g., asporogenic <i>Bacillus subtilis</i>
or <i>Bacillus licheniformis</i>, the K-12 strain of <i>Escherichia coli</i>)</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Risk
Group 2:</span></b><span style="font-family: "Palatino Linotype", serif;">
Microorganisms that are pathogenic, but unlikely to pose a serious hazard to
laboratory workers, livestock, the community, or the environment as effective
treatment and preventive measures to limit spread of infection are available.
These organisms thus are of moderate risk to the individual and low risk to the
community (e.g., <b>Bacterial agents</b>—<i>Aeromonas hydrophila, Escherichia
coli, Klebsiella spp., Salmonella spp.</i>; <b>Fungal agents</b>—<i>Penicillium
marneffei, Blastomyces dermatitidis</i>; <b>Parasitic agents</b>—<i>Ascaris
spp., Trypanosoma spp.</i>; <b>Viruses</b>—Adenoviruses, Coronaviruses,
Papilloma viruses)</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Risk
Group 3:</span></b><span style="font-family: "Palatino Linotype", serif;">
Microorganisms that are pathogenic and can cause serious human or animal
diseases but are not contagious or have effective treatment and preventive
measures. These organisms pose high risk to the individual, but low risk to the
community (e.g., <b>Bacterial agents</b>—<i>Brucella spp., Francisella
tularensis, Rickettsia spp.</i>; <b>Fungal agents</b>—<i>Coccidiodes immitis,
Histoplasma spp.</i>; <b>Viruses and prions</b>—Togaviruses, Flaviviruses such
as the Japanese encephalitis virus, West Nile virus, Pox viruses, prions such
as the transmissible spongiform encephalopathies, retroviruses such as Human Immunodeficiency
Virus, rhabdovirus)</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: large;"><b><span style="font-family: "Palatino Linotype", serif;">Risk
Group 4:</span></b><span style="font-family: "Palatino Linotype", serif;">
Microorganisms that usually cause serious diseases in humans and animals and
can be readily transmitted either directly or indirectly from one to the next
individual. Effective treatment and preventive measures are usually
unavailable. This class of organisms thus poses a high risk to individuals and
to the community (e.g., <b>Viral Agents</b> such as the Lassa virus, Ebola
virus, Marburg virus, Herpes virus simiae, Kayasanur Forest disease, Central
European encephalitis, and yet unidentified hemorrhagic fever agents).</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
NIH guidelines recognize that this classification is dependent on current
knowledge of pathogenicity, and with the development of better therapeutic and
preventive measures, pathogens may be assigned to a lower risk category. Different
countries may assign the same organism to different risk groups, possibly
because the same organism is more virulent in certain parts of the world than
others depending on climatic conditions and other factors. Also, any strain
more virulent than the wild-type parent strain should be assigned to a higher
risk group.</span></span></p><p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;"><br /></span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Good
Laboratory Practice (GLP)</span></span></b></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Good
Laboratory Practice embodies a set of principles that provide a framework
within which laboratory studies are planned, performed, monitored, recorded,
reported, and archived.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">The
primary purpose of GLP is to ensure uniformity, consistency, and reliability of
safety tests (nonclinical) for pharmaceuticals, agrochemicals, aroma and color
food/feed additives, cosmetics, detergents, novel foods, nutritional
supplements for livestock, and other chemicals. These safety tests are used to
generate data on various parameters from physicochemical properties to toxicity
(nonclinical) for use of regulatory authorities to make risk/safety
assessments.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Originally,
GLP regulations were intended for toxicity testing only and were reserved for
laboratories undertaking animal studies for preclinical work. GLP is now
followed in all laboratories where research or marketing studies are to be
submitted to regulatory authorities such as the FDA. Establishment of GLP is
mandatory to evaluate safety or toxicity of products intended to undergo
clinical trials.</span></span></p>
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Compliance
with GLP requires that:</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
tests should be conducted by qualified personnel.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">Each
study should have a Study Director responsible for the overall conduct of the
tests.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
laboratory study and the accompanying data should be audited by a Quality
Assurance Unit.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
laboratory activities must be performed in accordance with written and filed
management-approved Standard Operating Procedures (SOPs). SOPs should cover
policies, administration, equipment operation, technical operation, and
analytical methods.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">All
control and test articles and reagents must be identified, characterized, and labelled
with information regarding source, purity, stability, concentration, storage
conditions, and expiration date.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l3 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-size: large;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">6.<span style="font-family: "Times New Roman"; font-feature-settings: normal; font-kerning: auto; font-optical-sizing: auto; font-stretch: normal; font-style: normal; font-variant: normal; font-variation-settings: normal; font-weight: normal; line-height: normal;"> </span></span></span><span style="font-family: "Palatino Linotype", serif;">The
equipment must be maintained, calibrated, and must be designed to meet
analytical requirements.</span></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: large;">Compliance
with GLP has served to harmonize test methods across nations, facilitating
generation of mutually acceptable data, thus avoiding duplication of tests, and
saving time and resources.</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-19848986550665729602023-03-11T17:43:00.005+08:002023-03-11T21:57:22.025+08:00Performance Evaluation of Laboratory Staff<p><span style="color: #01ffff; font-size: medium;">Part of the compliance under JCI Standard (SQE.3 & </span><span style="color: #01ffff; font-size: large;">SQE.11</span><span style="color: #01ffff; font-size: large;">) is to have a performance evaluation of staff annually to assess their competency and ensure patient safety. Below is a sample template for performance evaluation</span></p><p><span style="color: #01ffff; font-size: medium;">To prevent any bias, any score below 3 should be supported by a document why such score was given to a laboratory staff. The evaluator should also note the number of correct behavior or competencies that the laboratory staff has provided that would invalidate any wrongdoing except of course when the action compromises patient safety. </span></p><p></p><div align="center">
<!--[if !supportMisalignedColumns]--><!--[endif]--><table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" valign="top" width="75">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 20pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 10cm;" valign="top" width="378">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 182.85pt;" valign="top" width="244">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 56.45pt;" valign="top" width="75">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">I.D. No.<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 10cm;" valign="top" width="378">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">FULL NAME<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 182.85pt;" valign="top" width="244">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">POSITION<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2; mso-yfti-lastrow: yes;">
<td colspan="2" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 106.1pt;" width="141">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 5pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span><span style="color: #01ffff;">COVERAGE PERIOD:</span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 233.85pt;" width="312">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 6pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 91.4pt;" width="122">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">CONTRACT DATE:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 91.45pt;" width="122">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr height="0">
<td style="border: none;" width="71"></td>
<td style="border: none;" width="52"></td>
<td style="border: none;" width="231"></td>
<td style="border: none;" width="109"></td>
<td style="border: none;" width="90"></td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 5pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184; width: 699px;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 38.9pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">Score<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 81.35pt;" width="108">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">Equivalent<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 404pt;" width="539">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">Interpretation<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 38.9pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 81.35pt;" width="108">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Excellent (E)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 404pt;" valign="top" width="539">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Demonstrates excellence in the expectation
and/or requirements of the competency<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 38.9pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 81.35pt;" width="108">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Very Good (VG)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 404pt;" valign="top" width="539">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Meets the expectations and/or
requirements of the competency<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 38.9pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 81.35pt;" width="108">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Good (G)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 404pt;" valign="top" width="539">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Has identified knowledge, skill and
attitudes for the required competency<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 38.9pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 81.35pt;" width="108">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Fair (F)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 404pt;" valign="top" width="539">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Needs improvement on the knowledge and
skills to meet the required competency<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 38.9pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 81.35pt;" width="108">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Poor (P)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 404pt;" valign="top" width="539">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Requires education and/or orientation
to meet the expectations and/or requirements of the competency<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 5pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" valign="top" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">No.<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">C O M P E T E N C I E S<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">E<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">VG<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">G<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">F<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">P<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">N/A<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly and independently performs
cross–matching and ABO Typing and confident with the result<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly identifies parasite in urine
or stool or blood sample <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly reads antibiotic sensitivity
from agar plate <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly classifies different White
Blood Cell on peripheral smear or presence in urine or stool or CSF samples <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly identifies abnormal Red
Blood Cell on peripheral smear or presence in urine or stool or CSF samples<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly interprets hematocrit value
and can preempt the need for blood transfusion <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">7<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly identifies cut–off limit for
Viral Markers and can proceed with the precautionary steps and report<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">8<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly identifies vein for
extraction<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">9<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Collect blood samples using
appropriate container <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">10<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly identifies quality &
quantity of sample for processing and informs concerned parties if repeat
collection is necessary<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">11<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly instruct the patient of
preparations prior to specimen collection (e.g. urine, stool, FBS) <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">12<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Practices aseptic technique in
performing venipuncture<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">13<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Applies post-extraction care for
patient and can identify patient needs during adverse reaction.<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">14<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Processes samples to meet the required
turnaround time <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">15<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Identifies patient correctly prior to
blood collection <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">16<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Appropriately ask question (such as
NPO, medications, etc.) from patient prior to specimen collection<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">17<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly preserves specimen as needed
using the correct technique/solution<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">18<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Advises the patient of the expected
availability of result<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">19<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Releases report within the turnaround
time <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">20<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Knows how to identify erratic results
and can identify the source of error<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">21<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Relays panic result in a timely manner
<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">22<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Correctly charges/bill patient for
requested examination <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">23<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Performs machine calibration prior to
use<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">24<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Performs basic troubleshooting of
machine when guided or instructed by a Biomedical Technician<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">25<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Archives quality control charts for
future reference and applies/calls for corrective measures when needed<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">26<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Orderly documents all Lab results for
easy access and reference<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">27<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Properly disposes sharp materials to
appropriate container <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">28<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Properly disposes specimen/materials
to an appropriate color–coded bags<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">29<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Stores reagents/supplies on
appropriate room/temperature <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">30<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Endorses specimen after cut-off to the
next shift<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">31<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Endorses pending samples after end of
shift <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 32;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">32<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Requests supplies upon reaching PAR
level<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 33;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">33<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Declutters area after end of shift <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 34;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">34<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Adherence to Universal Safety
Precaution (wearing of gloves and mask)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 35;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">35<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Stays on assigned post during duty
hours <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 36;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">36<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Adheres to assigned schedules and
punctually comes to work<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 37;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">37<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Polite and courteous when dealing with
patient <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 38;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">38<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Polite and courteous when dealing with
Physicians <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 39;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">39<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Polite and courteous when dealing with
Colleagues <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 40;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">40<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Attends huddle to discuss pertinent
laboratory issues <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 41;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" width="36">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">41<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Comes to work wearing appropriate
clothes<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 42;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" valign="top" width="36">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" width="436">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><b><span lang="EN-US"><span style="color: #01ffff;">TOTAL ITEMS<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 14pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 43;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" valign="top" width="36">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" valign="top" width="436">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><b><span lang="EN-US"><span style="color: #01ffff;">MULTIPLIER<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">x 5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">x 4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">x 3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">x 2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">x 1<o:p></o:p></span></span></p>
</td>
<td rowspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 31.2pt;" valign="top" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 44;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" valign="top" width="36">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" width="436">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><b><span lang="EN-US"><span style="color: #01ffff;">TOTAL SCORE (NUMERATOR)<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 30.15pt;" valign="top" width="40">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-size: 14pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 29.6pt;" valign="top" width="39">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.45pt;" valign="top" width="35">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.45pt;" valign="top" width="34">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 25.8pt;" valign="top" width="34">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 45;">
<td rowspan="2" style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 26.9pt;" valign="top" width="36">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td rowspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 327.25pt;" width="436">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><b><span lang="EN-US"><span style="color: #01ffff;">CALCULATIONS<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 59.75pt;" valign="top" width="80">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-size: 14pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" rowspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 51.9pt;" width="69">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 14pt;">x 100</span><span lang="EN-US"><o:p></o:p></span></span></p>
</td>
<td colspan="2" rowspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 57pt;" width="76">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><b><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">%</span><span lang="EN-US"><o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 46; mso-yfti-lastrow: yes;">
<td colspan="2" style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 59.75pt;" valign="top" width="80">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US" style="font-size: 14pt;"><span style="color: #01ffff;">205<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 5pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">95 % to 100 %<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">80% to 94%<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">60% to 79%<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">50% to 59%<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.6pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">49% Below<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Excellent<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Very Satisfactory<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Satisfactory<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.55pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Needs Improvement<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 104.6pt;" valign="top" width="139">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span lang="EN-US"><span style="color: #01ffff;">Unsatisfactory<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><br /></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 261.4pt;" valign="top" width="349">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">Employee’s Name & Signature<o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 261.4pt;" valign="top" width="349">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span lang="EN-US"><span style="color: #01ffff;">Evaluator’s Name & Signature<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 261.4pt;" valign="top" width="349">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: 1pt solid windowtext; border-left: none; border-right: 1pt solid windowtext; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 261.4pt;" valign="top" width="349">
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span lang="EN-US"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0; mso-yfti-lastrow: yes;">
<td style="border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 113.15pt;" width="151">
<p class="MsoNoSpacing"><span lang="EN-US"><span style="color: #01ffff;">Recommended Action:<o:p></o:p></span></span></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 136.55pt;" valign="top" width="182">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□</span><span lang="EN-US"> Retain for Contract<span style="mso-spacerun: yes;"> </span></span></span><span style="color: #01ffff;">Renewal / Continuation</span></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 136.55pt;" valign="top" width="182">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□ </span><span lang="EN-US">For Repeat Evaluation </span></span><span style="color: #01ffff;">after 3 months</span></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 136.55pt;" valign="top" width="182">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□ </span><span lang="EN-US">Not Eligible for Contract </span></span><span style="color: #01ffff;">Renewal</span></p>
</td>
</tr>
</tbody></table>
</div>
<p class="MsoNoSpacing"><span lang="EN-US" style="font-size: 9pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="height: 23.05pt; mso-yfti-firstrow: yes; mso-yfti-irow: 0; mso-yfti-lastrow: yes;">
<td style="border: 1pt solid windowtext; height: 23.05pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 261.4pt;" width="349">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 12pt;">Human Resource Manager Signature</span><span lang="EN-US"><o:p></o:p></span></span></b></p>
</td>
<td style="border-left: none; border: 1pt solid windowtext; height: 23.05pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0cm 5.4pt; width: 261.4pt;" valign="top" width="349">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><u><span lang="EN-US">Recommended Action</span></u><span lang="EN-US">: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□ </span><span lang="EN-US">Eligible for ____ % Salary Increment <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□ </span><span lang="EN-US">Not eligible for Salary Increment<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□ </span><span lang="EN-US">Transfer to Another Unit/Department<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□ </span><span lang="EN-US">Termination of Contract<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><span lang="EN-US" style="font-size: 16pt;">□ </span><span lang="EN-US">Others: __________________<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div><br /><p></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-85278017582561829782023-03-11T17:01:00.001+08:002023-03-11T22:10:31.268+08:00Joint Commission International Laboratory Standards<p><br /></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Joint
Commission International in an independent, not for profit international
organization that accredits and certifies health care organizations and
programs around the globe.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Although
the accreditation is voluntary, their list of standards ensures patient safety
and delivers quality healthcare that is acceptable universally.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">There
are different chapters in the accreditation standard and below are the one
which is applicable to a clinical laboratory.<span style="mso-spacerun: yes;"> </span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">JCI
Requirements are described in these categories:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l84 level1 lfo21; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Standards</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">JCI standards define the performance
expectation, structures, or functions that must be in place for a hospital to
be accredited by JCI. JCI’s standards are evaluated during the on–site survey.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l84 level1 lfo21; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Intents</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A standard’s intent helps explain the
full meaning of the standard. The intent describes the purpose and rationale of
the standard, provides an explanation of how the standard fits into the overall
program, sets parameters for the requirement(s), and otherwise “paints a
picture” of the requirements and goals. The bulleted lists in the intent
statement are considered advisory and serve as a helpful explanation of
practices that might meet the standard. Numbered or lettered lists in the
intent statement include required elements that must be in place to meet the
standard.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l84 level1 lfo21; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Measurable
Elements (MEs)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Measurable elements (MEs) of standard
indicate what is reviewed and assigned a score during the on–site survey
process. The MEs for each standard identify the requirements for full
compliance with the standard. The MEs are intended to bring clarity to the
standards and help the organization fully understand the requirements, educate
leadership, department/service leaders, healthcare practitioners, and staff
about the standards, and guide the organization in accreditation preparation.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The score will either be “met” or
“partially met” or “not met” based on the compliance of the laboratory.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">If a standard is “not met” or only
“partially met” a Strategic Improvement Plan (SIP) will be required especially
if it has an impact on patient safety and quality. The written SIP is expected
to do the following:</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l39 level1 lfo22; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Establish the strategies/approach
that the hospital will implement to address each identified finding.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l39 level1 lfo22; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Describe specific actions the
hospital will use to achieve compliance with the standards/MEs cited</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l39 level1 lfo22; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Describe specific steps the
hospital will use to communicate and educate its staff, physicians and other in
implementing actions to achieve compliance with the MEs cited.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l39 level1 lfo22; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Describe methodology to prevent
reoccurrence and to sustain improvement over time.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l39 level1 lfo22; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Identify the measures that will
be used to evaluate the effectiveness of the improvement plan.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The SIP must demonstrate that the
hospital’s actions lead to full compliance with the standards and MEs. The SIP
is reviewed and approved and accepted by the JCI Accreditation Office staff
after the Accreditation or Certification Letter and Gold Seal have been
awarded.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">An organization that fails to submit an
acceptable Strategic Improvement Plan (SIP) within 120 days of the
organization’s survey is placed at risk of accreditation denial and a follow–up
survey is required to verify evidence of compliance. When this occurs, the
client organization is notified and the follow–up survey protocol is
implemented. <o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">ASSESSMENT OF
PATIENT (AOP) STANDARD</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;"><o:p> </o:p></span></b></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
services are available to meet patient needs, and all such services meet
applicable local and national standards, laws, and regulations.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a system for providing laboratory services, including clinical
pathology services, required by its patient population, clinical services
offered, and health care practitioner needs. The laboratory services are
organized and provided in a manner that meets applicable local and national
standards, laws, and regulations.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
services, including those required for emergencies, may be provided within the
hospital, by agreement with another organization, or both. Laboratory services
are available after normal hours for emergencies. In addition, the hospital can
identify and to contact experts in specialized diagnostic areas, such as
parasitology, virology, or toxicology, when needed.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Outside
sources are convenient for the patient to access. The hospital selects outside
resources based on the recommendation of the laboratory’s leader or other
individual responsible for laboratory services. Outside sources of laboratory
services meet applicable laws and regulations and have an acceptable record of
accurate, timely services. Patients are informed when an outside source of
laboratory services is owned by the referring Physician.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory services meet
applicable local and national standards, laws, and regulations</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory services are available
to meet the needs related to the hospital’s mission and patient population, the
community’s health care needs, and emergency needs, including after normal
hours</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Experts in specialized diagnostic
areas are contacted when needed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Outside sources are selected
based on an acceptable record and compliance with laws and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient are informed about any
relationships between the referring Physician and outside sources of laboratory
services.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
qualified individual(s) is responsible for managing the clinical laboratory or
pathology services.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Clinical
laboratory services are under the direction of an individual who is qualified
by virtue or documented training, expertise, and experience, consistent with
applicable laws and regulations. This individual assumes professional
responsibility for the laboratory facility and the services provided in the
laboratory as well as tests performed outside the laboratory, such as testing
performed at bedside (point–of– care testing). The oversight of services
outside the laboratory includes ensuring consistent hospital wide policies and
practices, such as training and supply management, among others. It does not
include daily supervision of those activities. Daily supervision remains the
responsibility of the leaders of the department or unit in which the testing is
conducted.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
this individual provides clinical consultation or medical opinion, he or she is
a Physician, preferably a Pathologist. Specialty and subspecialty laboratory
services are under the direction of appropriately qualified individuals. Responsibilities
of the laboratory leader include:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Developing, implementing, and
maintaining policies and procedures</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Administrative oversight;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Maintaining any necessary quality
control program;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Recommending outside sources of
laboratory services; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Monitoring and reviewing all
laboratory services.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
elements of AOP.5.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The clinical laboratory and other
laboratory services throughout the hospital, are under the direction and
oversight of one or more qualified individuals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Responsibilities for developing,
implementing, and maintaining policies and procedures are defined and carried
out.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Responsibilities for
administrative oversight are defined and carried out.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Responsibilities for maintaining
quality control programs are defined and carried out.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Responsibilities for recommending
reference/contract laboratory services are defined and carried out.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l6 level1 lfo85; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Responsibilities for monitoring
and reviewing all laboratory services within and outside the laboratory are
defined and carried out.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.1.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
qualified individual is responsible for the oversight and supervision of the
point– of–care testing program.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.1.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Point–of–care
testing (POCT) </span></b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">is
defined by the College of American Pathologist as <i>“test designed to be used
at or near the site where the patient is located, that do not require
permanent, dedicated space and that are performed outside the physical
facilities of the clinical laboratories.”</i></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
POCT is included in the hospital services, oversight, and supervision for the
services, regardless of where the services are performed, are provided by the
individual responsible for managing the laboratory services or a designee. The
hospital must have a clearly defined and well–structured approach to POCT to
ensure that it is performed safely and correctly and that the results generated
are accurate and reliable.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
POCT program includes thorough planning with leaders electing to implement POCT
in their department/ward. Planning includes selection of tests to be performed,
identification of staff who will be performing the test(s), and a protocol for
reporting abnormal test results, including the process for reporting critical
results. Staff performing POCT require training for each test being performed,
along with a competency evaluation to ensure that results are accurate.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
control performance, documentation, and evaluation are required to be performed
within defined specifications, generally recommended by the manufacturer, daily
as well as between new batches of test kits. The quality control sample may be
included with the test kit or may need to be purchased from the manufacturer or
authorized representative. All staff performing POCT adhere to defined quality
control procedures and understand what actions to take when the quality control
samples is out of specification.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
POCT program should be monitored and evaluated to ensure that the program is
meeting the needs of its customers (health practitioners, testing staff, and patients).
This may be accomplished by developing and monitoring quality improvement
measures, through patient surveys and/or reviews of quality control and
Proficiency Testing results, and utilization reports.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.1.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l53 level1 lfo84; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The person responsible for
managing the laboratory services, or a designee, provides oversight and
supervision of the POCT program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l53 level1 lfo84; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff performing point–of–care
testing have the required qualifications and training and are competent to
perform POCT.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l53 level1 lfo84; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The POCT program includes a
defined process for reporting abnormal test results, including reporting of
critical results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l53 level1 lfo84; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The POCT program includes quality
control performance, documentation, and evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l53 level1 lfo84; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The POCT program is monitored and
evaluated and included in quality improvement activities.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">All
laboratory staff have the required education, training, qualifications, and
experience to administer and perform the tests and interpret the results.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital identifies the education, training, qualifications, and experience of
laboratory staff members performing and interpreting laboratory tests, those
who are approved to perform point–of–care screening tests at the bedside, and
those who direct or supervise staff who perform testing. Supervisory staff and
technical staff are oriented to their work. Technical staff are given work assignments
consistent with their training and experience. In addition, the laboratory
implements a staffing program that allows staff to perform tests promptly and
to ensure laboratory staffing during all hours of operation and for
emergencies.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
laboratory staff have the required credential to administer, perform and
interpret tests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
staffing program is implemented that allows staff to perform tests promptly and
to provide staffing during all hours of operation and during emergencies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
supervisory staff are identified and have the proper qualifications and
experience.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
laboratory safety program is in place, followed, and documented, and compliance
with the facility management and infection control programs is maintained.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory has an active safety program to the degree required by the risks and
hazards encountered in the laboratory. The program addresses safety practices
and prevention measures (for example, eye–wash stations, spill kits and the
like) for laboratory staff, other staff, and patients when present. The
laboratory program is coordinated with the hospital’s facility management and
infection control program.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory safety management program includes:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Compliance with standards
addressing facility management and infection control programs;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Compliance with local and
regional laws and regulations;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Availability of safety devices
appropriate to the laboratory’s practices and hazards encountered;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The orientation of all laboratory
staff to safety procedures and practices;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">In–service education for new
procedures and newly acquired or recognized hazardous materials.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
laboratory safety program addresses potential safety risks in the laboratory
and other areas outside the laboratory where laboratory services are provided.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
program is part of the hospital’s facility management and infection control
programs and reports to the hospital safety structure at least annually and
when any safety events occur.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Identified
safety risks are addressed by specific processes and/or devices to reduce the
safety risks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
staff are oriented to safety procedures and practices and receive ongoing
education and training for new practices and procedures.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.3.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory uses a coordinated process to reduce the risks of infection because
of exposure to infectious diseases and biohazardous materials and waste.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.3.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">There
are policies, procedures, and practices implemented to reduce the hazards of
exposure to biohazardous materials. Infections acquired in the laboratory are
reported internally and, when appropriate, to public health agencies. The
following biosafety hazards and practices are addressed in written procedures,
and the requirements of the procedures are followed:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Exposures
to aerosols and droplets are controlled (for example, when mixing, sonicating,
centrifuging, and flaming inoculating loops).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
coats, gowns, or uniforms are worn to protect street clothes and prevent
contamination.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Biosafety
cabinets are used when required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Rules
govern how to handle laboratory exposure to infectious agents, accidental cuts,
needlestick injuries, accidental ingestion, and contact of potentially
infectious agents with mucus membranes. These rules include decontamination
procedures, whom to contact for emergency treatment, and the location and use
of safety equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
are written procedures defining safe collection, transport, and handling of all
specimens. The procedure includes prohibiting anyone in laboratory technical
areas from eating, drinking, smoking, applying cosmetics, manipulating contact
lenses, and mouth pipetting.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
relevant to their jobs, staff have received training about precautionary
measures, modes of transmission and prevention of blood–borne pathogens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l8 level1 lfo7; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory also has a procedure to control exposure to infectious diseases,
such as Ebola, MERS, tuberculosis, Zika, and others.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
problems with practice are identified, or accidents occur, corrective actions
are taken, documented, and reviewed.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.3.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory has a defined process for reducing the risks of infection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Infections
acquired in the laboratory are reported, as defined in the policy, and in
compliance with applicable laws and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory follows biosafety rules for relevant practice address in elements
(a) through (g) in the intent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
problems with practice are identified, or accidents occur, corrective actions
are taken, documented, and reviewed.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.4</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
results are available in a timely way as defined by the hospital.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.4</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital defines the time period for reporting laboratory test results. Results
are reported within a time frame on patient needs, services offered, and
clinical staff needs. Emergency tests and after–hours and weekend testing needs
are included. Results from urgent tests, such as those from the emergency
department, operating theatres, and intensive care units are, are given special
attention in the quality measurement process. In addition, when laboratory
services are by contract with an outside organization, the reports are also
timely, as set forth by hospital policy or the contract.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.4</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has established the expected report time for results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
timeliness of reporting of urgent/emergency tests is measured.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
results are reported within a time frame to meet patient needs.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">All
equipment used for laboratory testing is regularly inspected, maintained, and
calibrated, and appropriate records are maintained for these activities.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
staff work to ensure that all equipment, including medical devices used for
point–of–care testing, function at acceptable levels and in a manner that is
safe to the operator(s). The laboratory develops and implements a program to
manage equipment and medical equipment that provides for:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Selecting and acquiring
laboratory equipment and medical equipment;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Identifying and taking inventory
of laboratory equipment and medical equipment;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Assessing laboratory equipment
use through inspection, testing, calibration, and maintenance;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Monitoring and acting on
laboratory equipment hazard notices, recalls, reportable incidents, problems,
and failures; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documenting the management
program.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Testing,
maintenance, and calibration frequency are related to the laboratory’s use of
its equipment and its documented history of service.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.5</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory develops, implements, and documents a program to manage laboratory
equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
program identifies how laboratory equipment is selected and acquired.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a documented inventory of all equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
equipment is inspected and tested when new and according to age, use, and
manufacturer’s recommendations thereafter and the inspections are documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Laboratory
equipment is calibrated and maintained according to manufacturer’s
recommendations, and the calibration and maintenance are documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a system in place for monitoring and acting on laboratory
equipment hazard notices, recalls, reportable incidents, problems, and
failures.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Essential
reagents and supplies are available, and all reagents are evaluated to ensure
accuracy and precision of results.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has identified those reagents and supplies necessary to provide
laboratory services to its patients. There is a process to order or secure
those essential reagents and supplies.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">All
reagents are stored and dispensed according to manufacturers’ directives or
packaging instructions. All reagents are evaluated according to written
guidelines. Written guidelines ensure the complete and accurate labelling of
reagents and solutions.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.6</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Essential
reagents and supplies are identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Essential
reagents and supplies are available, and there is a process to address when
essential reagents are not available.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
reagents are stored and dispensed according to manufacturers’ directives or
packaging instructions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory establishes and follows written guidelines for the evaluation of all
reagents to ensure accuracy and precision of results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
reagents and solutions are completely and accurately labelled.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.7</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
for collection, identifying, handling, safely transporting, and disposing of
specimen are established and implemented.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.7</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
are established and implemented for:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Ordering tests;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Collecting, storing, and
preserving specimens; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Receiving, logging, and tracking
specimens.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">These
procedures are observed for specimens sent to reference/contract laboratory
services for testing.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.7</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
are established and implemented for the ordering of tests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
are established and implemented for the collection and identification of
specimens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
are established and implemented for the transport, storage, and preservation of
specimens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
are established and implemented for the receipt and tracking of specimens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
are established and implemented for the disposal of specimens.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
procedures are followed when reference/contract laboratory services are used.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Established
norms and ranges are used to interpret and to report clinical laboratory
results.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
AOP.5.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory establishes reference intervals or “normal” ranges for each test
performed. The range is included in the medical record, either as part of the
report or by including a current listing such values approved by the laboratory
leader. Ranges are furnished when reference/contract laboratory service
performs the test. The reference ranges are appropriate to the hospital’s
geography and demographics are reviewed and updated when methods change.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.8</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory has established reference ranges for each test performed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
range is included in the medical record at the time test results are reported.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Ranges
are furnished when tests are performed by reference/contract laboratory
services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Ranges
are appropriate to the hospital’s geography and demographics.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Ranges
are reviewed and updated as needed.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.9</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
control procedures for laboratory services are in place, followed, and
documented.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.9.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a process for Proficiency Testing of laboratory services.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.9 and AOP.5.9.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Well–designed
quality control systems are essential to providing excellent pathology and
clinical laboratory services.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Validation of the test methods
used for accuracy, precision, and reportable range;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Daily surveillance of results by
qualified laboratory staff;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Testing of reagents;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Rapid corrective action when a
deficiency is identified; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documentation of results and
corrective actions.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Proficiency
testing determines how well an individual laboratory’s results compare with
other laboratories that use the same methodologies. Such testing can identify
performance not recognized by internal mechanisms. Thus, the laboratory
participates in an approved Proficiency Testing program when available.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Alternatively,
when approved programs are not available, the laboratory exchanges samples with
a laboratory in another organization for purposes of peer comparison testing.
The laboratory maintains a cumulative record of participation in a Proficiency
Testing, or an alternative, is carried out for all specialty laboratory
programs when available.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.9</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital establishes and implements a quality control program for the clinical
laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
program includes the validation of test methods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
program includes the daily surveillance and documentation of test results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
program includes testing of reagents.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
program includes rapid correction and documentation of deficiencies.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.9.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
Laboratory participates in a Proficiency Testing Program, or an alternative for
all specialty laboratory services and tests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">For
each specialty, subspecialty, analyte, or test, the laboratory’s Proficiency
Testing results meet satisfactory performance criteria in accordance with laws
and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory maintains records of its participation in a Proficiency Testing
program.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.10</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Reference/contract
laboratories used by the hospital are licensed and accredited or certified by a
recognized authority.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.10.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital identifies measures for monitoring the quality of the services to be
provided by the reference/contract laboratory.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.10 and AOP.5.10.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
the hospital uses the services of a reference/contract laboratory – whether for
select tests or to provide all laboratory services – the following information
is required:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l33 level1 lfo16; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
copy of a license from a recognized licensing authority</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l33 level1 lfo16; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
copy of the certificate or letter of accreditation or certification from a
recognized laboratory accreditation or certification program*</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l33 level1 lfo16; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documentation
that the reference (contract) laboratory participates in an outside Proficiency
Testing program</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">*A recognized laboratory accreditation
or certification program is one that has been reviewed and endorsed by a laboratory
professional society or governmental or private agency.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">In
addition, the hospital identifies measures for monitoring the quality of the
services provided by all reference/contract laboratories – for example,
turnaround times for tests, critical results reporting, and problems with
specimens such as missing identifiers or specimen rejections. Qualified
individuals review and act on the results of the quality monitoring.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.10</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital maintains a copy of the license, from a recognized authority, for all
reference/contract laboratories used by the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital maintains a copy of the certificate or Letter of Accreditation or
certification, from a recognized laboratory accreditation or certification
program, for all reference/contract laboratories used by the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital maintains documentation that any reference/contract laboratory used by
the hospital participates in an outside Proficiency Testing program.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.10.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
frequency and type of performance expectation data from reference/contract
laboratories are determined by the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
qualified individual responsible for the laboratory or a qualified designee
reviews the performance expectation data from reference/contract laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
responsible individual or qualified designee acts based on the results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An
annual report of the data from reference/contract laboratories is provided to
hospital leadership to facilitate management of contracts and contract
renewals.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
AOP.5.11</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
qualified individual is responsible for blood bank and/or transfusion services
and ensures that services adhere to laws and regulations and recognized
standards of practice.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of AOP.5.11</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
bank and/or transfusion services, when provided by the hospital, are under the
direction of an individual who is qualified by virtue of documented training,
expertise, and experience, consistent with applicable laws and regulations.
This individual assumes professional responsibility for all aspects of blood
bank services provided in the hospital. The oversight of services includes
establishment, implementation, and documentation of the processes for:</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
donor selectio</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
screening for disease</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
collection</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
storage</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Compatibility
testing</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
distribution</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
control processes for all blood bank services are established, implemented, and
documented to ensure the safety of blood bank and transfusion services. Blood
donor and transfusion services are guided by laws and regulations and
recognized standards of practice.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of AOP.5.11</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
qualified individual is responsible for blood bank and/or transfusion services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
blood bank has established, implemented, and documented processes for (a)
through (f) of the intent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
control measures are in place for all blood bank and transfusion services and
are established, implemented, and documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #fcff01;">The
blood bank and transfusion services comply with applicable laws and regulations
and recognized standard of practice. </span><o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">INTERNATIONAL PATIENT
SAFETY GOALS (IPSG) STANDARDS</span></b></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
IPSG.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital develops and implements a process to improve accuracy of patient
identification.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of IPSG.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Wrong–patient
errors occur in virtually all aspects of diagnosis and treatment. Patients may
be sedated, disoriented, not full alert, or comatose; may change beds, rooms,
or locations within the hospital; may have sensory disabilities; may not
remember their identity; or may be subject to other situations that may lead to
errors in correct identification. The intent of this goal is twofold: first, to
reliably identify the individual as the person for whom the service or treatment
is intended; second, to match the service or treatment to that individual.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
identification process used throughout the hospital requires at least two ways
in which to identify a patient, such as the patient’s name, identification
number, birth date, a bar–coded wrist band, or other ways. The patient’s room
number or location in the hospital cannot be used for identification. The
process for using two different patient identifiers is uniform throughout the
hospital. However, the two identifiers used in the inpatient department may be
different from the two identifiers in the outpatient department. For example,
the patient’s name and identification number or medical record number may be
used in all inpatient areas, and the patient’s name and birth date may be used
in all outpatient departments, such as the emergency department, ambulatory
care department, or other outpatient location.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">There
are special circumstances in which the hospital may need to develop a specific
process for patient identification; for example, when a comatose or
confused/disoriented patient arrives with no identification, in the case of a
new-born when the parents have not immediately chosen a name, and other
examples. The process considers the unique needs of the patients, and staff use
the process for patient identification in these special circumstances to
prevent error.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Two
different patient identifiers are required in any circumstances involving
patient interventions. For example, patient is identified before providing
treatments (such as administering medications, blood, or blood products;
serving a restricted diet tray; or providing radiation therapy); performing
procedures (such as insertion of an intravenous line or hemodialysis); and
before any diagnostic procedures (such as taking blood or other specimen for
clinical testing, or performing a cardiac catheterization or diagnostic
radiology procedure).</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of IPSG.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient
are identified using two patient identifiers, not including the use of the
patient’s room number and location in the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patients
are identified before performing diagnostic procedures, providing treatments,
and performing other procedures (e.g. phlebotomy).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital ensures the correct identification of patients in special
circumstances, such as the comatose patient or new-born who is not immediately
named.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
IPSG.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital develops and implements a process to improve the effectiveness of verbal
and/or telephone communication among caregivers.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
IPSG.2.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital develops and implements a process for reporting critical results of
diagnostic tests.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
IPSG 2.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital develops and implements a process for handover communication.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of IPSG.2 through IPSG2.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Effective
communication, which is timely, accurate, complete, unambiguous, and understood
by the recipient, reduces errors and results in improved patient safety.
Communication can be electronic, verbal, or written. Patient care circumstances
that can be critically impacted by poor communication include verbal and
telephone patient care orders, verbal and telephone communication of critical
test results, and handover communications.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient
care orders given verbally in–person and over the telephone, if permitted under
local laws and regulations, are some of the most error–prone communications.
Different accents, dialects, and pronunciations can make it difficult for the
receiver to understand the order being given. For example, drug names and
numbers that sound alike, such as erythromycin and azithromycin or fifteen or
fifty, can affect the accuracy of the order. Background noise, interruptions,
and unfamiliar drug names and terminology often compound the problem. Once,
received, a verbal order must be transcribed as a written order, which adds
complexity and risk to the ordering process.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
reporting of critical results of diagnostic tests is also a patient safety
issue. Diagnostic tests include but are not limited to laboratory tests,
radiology exams, nuclear medicine exams, ultrasound procedures, magnetic
resonance imaging, and cardiac diagnostics. This includes critical results from
any diagnostics tests performed at the bedside, such as point–of–care testing,
portable radiographs, bedside ultrasounds, or transesophageal echocardiograms.
Results that are significantly outside the normal range may indicate a
high–risk or life–threatening condition. A formal reporting system that clearly
identifies how critical results of diagnostic tests are communicated to health
care practitioners and how the information is documented reduces patient risks.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Handover
communications can also be referred to as handoff communications. Handovers of
patient care within a hospital occur:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Between health care practitioners
(for example, physician to physician, physician to nurse, nurse to nurse, and
so on);</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Between different levels of care
in the same hospital (for example, when the patient is moved from an intensive
care unit to a medical unit or from an emergency department to the operating
theatre);</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">From inpatient unit to diagnostic
or other treatment departments, such as radiology or physical therapy; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Between staff and
patients/families, such as at discharge.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Breakdowns
in communication can occur during any handover of patient care and can result
in adverse events. Interruptions and other distractions from unit activities
can inhibit clear communication of important patient information. Standardized,
critical content for communication between the patient, family, caregiver, and
health care practitioners can significantly improve the outcomes related to
handovers of patient care.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Standardized
forms, tools, or methods support a consistent and complete handover process.
The content of the handover communication and the form, tool, or method used is
standardized for the type of handover. The handover process may be different
for different types of handovers within the hospital. For example, handovers of
patient care for the emergency department to a medical ward may require a
different process or different content than handovers for the operating theatre
to the intensive care unit; however, the handovers are standardized for the
type of handover occurring. Handover forms or tools, if used by the hospital,
are not required to be part of the medical record. In addition, the detailed
information communicated during the handover is not required to be documented
in the medical record; however, the hospital may want to have documentation
that the handover occurred. For example, the health care practitioner would
record that he or she completed the handover and to whom he or she endorsed
care, and then sign, date, and time the entry.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Safe
practices for effective communication include the following:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Limiting verbal communication of
prescription or medication orders to urgent situations in which immediate written
or electronic communication is not feasible. For example, verbal orders can be
disallowed when the prescriber is present, and the patient’s chart is
available. Verbal orders can be restricted to situations in which it is
difficult or impossible for hard–copy or electronic order transmission, such as
during a sterile procedure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The development of guidelines for
requesting and receiving test results on an emergency or STAT basis, the
identification and definitions of critical tests and critical values, to whom
and by who critical test results are reported and monitoring compliance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Writing down, or entering to a
computer, the complete order or test result by the receiver of the information;
the receiver reading back the order or test result; and the sender confirming
that what has been written down and read back is accurate. Permissible
alternatives for when the read–back process may not always be possible may be
identified, such as in the operating theatre and in emergent situations in the
emergency department or intensive care unit.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use of standardized, critical
content for communication between the patient, family, health care
practitioner, and others involved in the patient’s care during handovers of
patient care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use of standardized methods, forms,
or tools to facilitate consistent and complete handovers of patient care.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of IPSG.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
complete <i><u>verbal</u> </i>order is documented and read back by the receiver
and confirmed by the individual giving the order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
complete <i><u>telephone</u></i> order is documented and read back by the
receiver and confirmed by the individual giving the order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
complete <i><u>test result</u></i> is documented and read back by the receiver
and confirmed by the individual giving the result.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of IPSG.2.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has defined critical values for each type of diagnostic test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has identified by whom and to whom critical results of diagnostic
tests are reported.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has identified what information is documented in the medical record.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of IPSG.2.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Standardized
critical content is communicated between health care practitioners during
handover of patient care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Standardized
forms, tools, or methods support a consistent and complete handover process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Data
from adverse events resulting from handover communications are tracked and used
to identify ways in which handover can be improved, and improvements are
implemented.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
IPSG.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital adopts and implements evidence–based hand–hygiene guidelines to reduce
the risks of healthcare–associated infections.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of IPSG.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Infection
prevention and control are challenging in most healthcare settings, and rising
rates of healthcare–associated infections are a major concern for patient and
healthcare practitioners. Infections common to all healthcare settings include
catheter–associated urinary tract infections, bloodstream infections, and
pneumonia (often associated with mechanical ventilation).</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Central
to the elimination of these and other infections is proper hand hygiene.
Evidence–based hand–hygiene guidelines are available from the World Health
Organization (WHO), the United States Center for Disease Control and Prevention
(US CDC), and various other national and international organizations.</span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The
hospital adopts and implements current evidence–based hand–hygiene guidelines.
Hand–hygiene guidelines are posted in appropriate areas, and staff are educated
in proper hand–washing and hand–disinfection procedures. Soap, disinfectants,
and towels or other means of drying are in those areas where hand–washing and
hand–disinfecting procedures are required.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of IPSG.5</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has adopted current evidence–based hand–hygiene guidelines.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital implements a hand–hygiene program throughout the hospital.</span></span></p><p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"></p><div style="text-align: center;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="400" src="https://www.youtube.com/embed/3PmVJQUCm4E" title="YouTube video player" width="510"></iframe></div><p></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #fcff01;">Hand–washing
and hand–disinfection procedures are used in accordance with hand–hygiene
guidelines throughout the hospital. </span><o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">PATIENT AND
FAMILY RIGHTS (PFR) STANDARDS</span></b></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PFR.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital is responsible for providing processes that support patients’ and
families’ right during care.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PFR.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital leadership is primarily responsible for how a hospital will treat its
patients. Thus, leadership needs to know and to understand patient and family
rights and the hospital’s responsibilities as identified in laws and
regulations. Leadership then provides direction to department/service leaders
who ensure that staff throughout the hospital assume responsibility for
protecting these rights. To effectively protect and to advance patient rights,
leadership works and seeks to understand their responsibilities in relation to
the community served by the hospital.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital respects the right of patient, and in some circumstances the right of
the patient’s family, to have the prerogative to determine what information
regarding their care would be provided to family or others, and under what
circumstances. For example, the patient may not wish to have a diagnosis or
laboratory result shared with family, or the family may not want the patient to
know his or her diagnosis.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient
and family rights are a fundamental element of all contacts among hospital, its
staff, and patients and families. Thus, policies and procedures are developed
and implemented to ensure that all staff members are aware of and respond to
patient and family rights issues when they interact with and care for patients
throughout the hospital. The hospital uses a collaborative and inclusive
process to develop the policies and procedures and includes patients and
families in the process.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PFR.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospital
leadership works to protect and to advance patient and family rights.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospital
leadership understands patient and family rights as identified in laws and
regulations and in relation to the cultural practices of the community or
individual patients served.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital respects the rights of patients, and in some circumstances the right
of the patient’s family, to have the prerogative to determine what information
regarding their care would be provided to family or others, and under what
circumstances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
staff are knowledgeable about patient rights and can explain their
responsibilities in protecting patient rights.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PFR.1.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides care that supports patient dignity, is respectful of the
patient’s personal values and beliefs, and responds to requests for spiritual
and religious observance.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PFR.1.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">One
of the most important human needs is the desire for respect and dignity. Often,
patients experience feelings of loss due to increased dependency in situations
such as the need for assistance with feeding, movement, and personal hygiene.
The patient has the right to care that is always respectful and considerate, in
all circumstances, and recognizes the patient’s personal worth and
self–dignity.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
patient brings his or her own set of values and beliefs to the care process.
Some values and beliefs are commonly held by all patients and are frequently
cultural and religious in origin. Other values and beliefs are those of the
patient alone. All patients are encouraged to express their beliefs in ways
that respect the beliefs of others.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Strongly
held values and beliefs can shape the care process and how patients respond to
care. Thus, all staff seek to understand the care and services they provide
within the context of the patient’s values and beliefs.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
a patient or family wishes to speak with someone related to religious or
spiritual needs or observe a spiritual or religious custom, the hospital has a
process to respond to the request. The process may be carried out through
on–site religious staff, local sources, or family–referred sources. The process
to respond is more complex; for example, when the hospital or country does not
officially “recognize” and/or have sources related to a religion or belief for
which there may be a request.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable Elements
of PFR.1.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
provide care that is respectful and considerate of the patient’s dignity and self-worth.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patients’
values and beliefs are identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
provide care that is respectful of the patient’s values and beliefs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital responds to routine as well as complex requests related to religious
or spiritual support.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PFR.1.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
patient’s rights to privacy and confidentiality of care and information are
respected.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PFR.1.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient
privacy, particularly during clinical interviews, examinations,
procedures/treatments, and transport, is important. Patient may desire privacy
from other staff, from other patients, and even from family members. Also,
patients may not wish to be photographed, to be recorded, or to participate in
accreditation survey interviews. Although there are some common approaches to
providing privacy for all patients, individual patients may have different or
additional privacy expectations and needs according to the situation, and these
expectations and needs may change over time. Thus, as staff members provide
care and services to patients, they inquire about the patient’s privacy needs
and expectations related to the care or service. This communication between a
staff member and his or her patient builds trust and open communication and
does not need to be documented.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
and other health information, when documented and collected, is important for
understanding the patient and his or her needs and for providing care and
services over time. This information may be in paper or electronic form or a
combination of the two. The hospital respects such information as confidential
and has implemented policies and procedures that protect such information from
loss or misuse. The policies and procedures reflect information that is
released as required by laws and regulations.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
respects patient privacy and confidentiality by not posting confidential
information on the patient’s door or at the nursing station and by not holding
patient –related discussion in public places. Staff are aware of laws and
regulations governing the confidentiality of information and inform patients
about how the hospital respects their privacy and the confidentiality of
information. Patients are also informed about when and under what circumstances
information may be released and how their permission will be obtained.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a policy that indicates if patients have access to their health
information and the process to gain access when permitted.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PFR.1.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
members identify patient expectations and needs for privacy during care and
treatment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
patient’s expressed need for privacy is respected for all clinical interviews,
examinations, procedures/treatments, and transport.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Confidentiality
of patient information is maintained according to laws and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patients
are requested to grant permission for the release of information not covered by
laws and regulations.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PFR.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital informs patients and families about is processed to receive and to act
on complaints, conflicts, and difference of opinion about patient care and the
patient’s right to participate in these processes.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PFR.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Patients
have a right to voice complaints about their care and to have those complaints
reviewed and, when possible, resolved. Also, decisions regarding care sometimes
present questions, conflicts, or other dilemmas for the hospital and the
patient, family, or other decision makers. These dilemmas may arise from issues
of access, treatment, or discharge. They can be particularly difficult to
resolve when the issues involve, for example, withholding resuscitative
services or foregoing or withdrawing life–sustaining treatment.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has established process for seeking resolution of such dilemmas and
complaints. The hospital identifies in policies and procedures those who need
to be involved in the processes and how the patient and family participate.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PFR.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patients
are informed about the process for voicing complaints, conflicts, and
differences of opinion.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Complaints,
conflicts, and differences of opinion are investigated by the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Complaints,
conflicts, and differences of opinion that arise during the care process are
resolved.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patients
and families participate in the resolution process.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PFR.5.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Informed
consent is obtained before surgery, anesthesia, procedural sedation, use of
blood and blood products, and other high–risk treatments and procedures.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PFR.5.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
the planned care includes surgical or invasive procedures, anesthesia,
procedural sedation, <i>use of blood and blood products</i>, or other high–risk
treatments or procedures, a separate consent is obtained. This consent process
provides the information identified in PFR.5.3 and documents the identity of
the individual providing the information.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Not
all treatments and procedures require a specific, separate consent. Each
hospital identifies those high–risk procedures and treatments for which consent
must be obtained. The hospital lists these procedures and treatments and
educates staff to ensure that the process to obtain consent is consistent. The
list is developed collaboratively by those physicians and others who provide
the treatments or perform the procedures. The list includes procedures and
treatments provided on an outpatient basis and inpatient basis.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PFR.5.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Consent
is obtained before surgical or invasive procedures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Consent
is obtained before anesthesia or procedural sedation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Consent
is obtained before the use of blood and blood products.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has listed those additional procedures and treatments that require
separate consent.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 12pt;">Consent
is obtained before the additional and/or other high–risk procedures and
treatments.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PFR.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital informs patients and families about how to choose to donate organs and
other tissues.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PFR.6.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides oversight for the process of organ and tissue procurement.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PFR.6 and PFR.6.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
shortage of available organs for transplant has encouraged may countries to
develop procedures and systems to increase that supply. In some countries, laws
determine that everyone is a donor unless specified otherwise (which is
considered presumed consent). In other countries, explicit consent for organ
donation is required. The hospital is responsible for defining the process of
obtaining and recording consent for cell, tissue, and organ donation in
relation to international ethical standards, and the way organ procurement is
organized in their country. The hospital has a responsibility to ensure that
adequate controls are in place to prevent patients from feeling pressured to
donate.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital supports the choice of patients and families to donate organs and
other tissues for research or transplantation. Information is provided to
patients and families on the donation process and the way organ procurement is
organized for the community, region or nation (such as national or regional
organ procurement agency or network).</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
shortage of organs for transplant has resulted in questionable practices in the
procurement and transplantation of organs. The practice of inducing vulnerable
individuals or groups (such as illiterate and impoverished persons,
undocumented immigrants, prisoners and political or economic refugees) to
become living donors, organ trafficking (the buying and selling of organs over
black market trade), the harvesting of organs without consent from executed
prisoners or dead patients, and transplant tourism are inconsistent with
ensuring organ donor and recipient safety.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Oversight
for the process of organ and tissue procurement includes defining the donation
process that is consistent with laws and regulations, respecting the
community’s religious and cultural values, ensuring ethical practices, and
identifying requirements for consent. Hospital staff are trained on the donation
process that supports patient and family choices. Staff are also trained in the
contemporary concerns and issues related to organ donation and availability of
transplants. The hospital cooperates with other hospitals and agencies in the
community responsible for all or a portion of the procurement, banking,
transportation, or transplantation process.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PFR.6</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital supports patient and family choices to donate organs other tissues.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides information to patients and families on the donation process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides information to the patient and family on the way organ
procurement is organized.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital ensure that adequate controls are in place to prevent patients from
feeling pressured to donate.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PFR.6.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital defines the organ– and tissue–donation processes and ensure that the
process is consistent with the region’s laws and regulations and its religious
and cultural values.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital identifies consent requirements and develops a consent process
consistent with those requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
are trained in the contemporary issues and concerns related to organ donation
and the availability of transplants.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital cooperates with relevant hospitals and agencies in the community to
respect and to implement choices to donate.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">CARE OF PATIENT
(COP) STANDARDS</span></b></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
COP.2.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital develops and implements a uniform process for prescribing orders.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of COP.2.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Many
patient care activities require a qualified individual to prescribe an order
for that activity that must be documented in the patient medical record. Such
activities may include, for example, orders for laboratory testing,
administration of medications, specific nursing care, nutrition therapy,
rehabilitative therapy, and the like. Patient care activities requiring orders
are ordered by individuals qualified to do so. Such orders must be easily
accessible if they are to be acted on in a timely manner. Locating orders on a
common sheet or in a uniform location in the patient’s medical record
facilitates the carrying out of orders. Documented orders help staff understand
the specifics of an order, when the order is to be carried out, and who is to
carry out the order. Orders can be written on an order sheet that is
transferred to the patient’s medical record periodically or at discharge, or a
computerized order entry system may be used in hospitals that are using
electronic patient medical records.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
hospital decides</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Which orders must be
written/documented and not by telephone, verbal, or test messaging (if verbal,
telephone, or text orders are allowed). For example, telephone orders may be
limited to emergency situations when a Physician is not present, verbal orders may
be limited to situations in which the ordering physician is performing a sterile
procedure, and texting orders may be limited to diagnostic tests only;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Which diagnostic imaging and
clinical laboratory test orders must provide a clinical indication/rationale;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any exceptions in specialized
settings, such as emergency departments and intensive care units;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Who is permitted to prescribe
orders;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where orders are to be in the
patient medical record, including those that may be received via text.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">As
technology has evolved, many licensed independent practitioners have begun to
use their personal mobile devices to text orders to the hospital for patient
care, treatment, or services. Current text messaging platforms may offer the
functionality to address previous concerns related to accuracy, timeliness,
documentation, confidentiality, security of information and patient safety.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">If
a hospital chooses to allow orders to be transmitted through text messaging,
the hospital ensures a secure text messaging platform is implemented and
includes the following:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo35; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Securing
sign–on process(es)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo35; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Encrypted
messaging</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo35; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Prohibited
use of unsecured test messaging (for example, short message service (SMS) text
messaging)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo35; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Delivery
and read receipts.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo35; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Date
and time stamp</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo35; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Customized
message retention time frames</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l5 level1 lfo35; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
process for authentication by the ordering physician</span></span></p>
<p class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of COP.2.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital develops and implements a uniform process for prescribing
written/documented patient orders that includes identifying orders that may be received
verbally, via telephone, and via text.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Diagnostic
imaging and clinical laboratory test orders include a clinical
indication/rationale when required for interpretation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Orders
are prescribed only by those qualified to do so.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Orders
are found in a uniform location in medical records.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
hospitals allow orders to be transmitted through text messaging, the hospital
ensures that process is through a secure text messaging platform and complies
with (a) through (g) in the intent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
hospitals allow orders to be transmitted through text messaging, the hospital
collects data to monitor the process of communication for clarification when
questions arise.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
COP.3.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Clinical
guidelines and procedures are established and implemented for the handling,
use, and administration of blood and blood products.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of COP.3.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
must be administered in accordance with standards of practice and in a
consistent manner in order to ensure the safety of the recipient. Therefore,
clinical guidelines and procedures describe the process for:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo37; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient
consent for administration</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo37; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procurement
of blood from the blood bank or blood storage area;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo37; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient
identification;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo37; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Blood
administration;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo37; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Monitoring
of the patient; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l2 level1 lfo37; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Identification
and response to signs of potential transfusion reactions</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">An
individual with the education, knowledge, and expertise to oversee the blood
and blood products administration ensures that processes, procedures, and
clinical guidelines for transfusion are defined and implemented.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of COP.3.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An
individual with education, knowledge and expertise oversees the administration
of blood and blood products.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Clinical
guidelines and procedures are established and implemented for the handling,
use, and administration of blood and blood products.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #fcff01;">Clinical
guidelines and procedures address the process for (a) through (f) in the
intent. </span><o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">PREVENTION AND CONTROL
OF INFECTION (PCI) STANDARDS</span></b></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PCI.7.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital reduces the risk of infections through proper disposal of waste.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PCI.7.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospitals
produce considerable waste each day. Frequently that waste is or could be
infectious. Thus, the proper disposal of wate contributes to the reduction of
infection risk in the hospital. This is true for the disposal of body fluids
and materials contaminated with body fluids, the disposal of blood and blood
components, and the disposal of waste from the mortuary and post mortem area,
when present.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PCI.7.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Disposal
of infectious waste and body fluids is managed to minimize infection
transmission risk.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
handling and disposal of blood and blood components are managed to minimize
infection transmission risk.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Operation
of the mortuary and post-mortem area is managed to minimize infection
transmission risk.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
PCI.7.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital implements practices for safe handling and disposal of sharps and
needles.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of PCI.7.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">One
of the dangers of needlestick injuries is the possible transmission of blood–
borne diseases. Incorrect handling and improper disposal of sharps and needles
present a major staff safety challenge. Work practices influence the risk of
injury and potential exposure to disease. Identifying and implementing
evidence–based practices to reduce the risk of injury from sharps ensures that
exposure to such injuries is minimal. Hospitals need to provide staff with
education related to safe handling and management of sharps and needles.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Proper
disposal of needles and sharps also reduces the risk of injury and exposure.
Proper disposal includes the use of containers that are closable,
puncture–proof, and leakproof on the sides and the bottom. Containers should be
easily accessible to staff and should not be overfilled.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Disposal
of discarded needles, scalpels and other sharps, when not done properly, can
pose a health risk to the general public and to those who work in waste
management. Disposing of sharps container in the ocean, for example, can pose
risks to the public if the containers break open. Hospitals must dispose of
sharps and needles safely or contract with organizations that ensures the
proper disposal of medical waste containers and that do so in accordance with
laws and regulations.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital implements a policy that adequately addresses all steps in the
process, including identifying the proper type and use of containers, the
disposal of the containers, and the surveillance of the process of disposal.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of PCI.7.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital identifies and implements practices to reduce the risk of injury and
infection from the handling and management of sharps and needles</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Sharps
and needles are collected in dedicated, closable, puncture–proof, leakproof
containers that are not reused.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #fcff01;">The
hospital disposes of sharps and needles safely or contracts with sources that
ensure the proper disposal of sharps containers in dedicated hazardous waste
sites or as determined by national laws and regulations. </span><o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">FACILITIES
MANAGEMENT AND SAFETY (FMS) STANDARDS</span></b></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
FMS.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital establishes and implements a program for inspecting, testing, and
maintaining medical equipment and documenting the results.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of FMS.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">To
ensure that medical equipment is available for use and functioning properly,
the hospital performs and documents:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An inventory of medical
equipment;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Regular inspections of medical
equipments;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Testing of medical equipment
according to its use and manufacturers’ requirements; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Performance of preventive
maintenance.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Qualified
individuals provide these services. Medical equipment is inspected when new and
then on an ongoing basis, according to the equipment, age, use, and
manufacturers’ instructions. Inspections, testing results, and any maintenance
are documented. This helps ensure the continuity of the maintenance process and
helps when doing capital planning for replacements, upgrades and other changes.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of FMS.8</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital establishes and implements a medical equipment program throughout the
hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is an inventory of all medical equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
equipment is inspected and tested when new and according to age, use, and
manufacturers’ recommendation thereafter.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
medical equipment program includes preventive maintenance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #fcff01;">Staff
providing these services are qualified and trained for the services being
provided. </span><o:p></o:p></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">STAFF QUALIFICATION
AND EDUCATION (SQE) STANDARDS</span></b></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.1.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
staff member’s responsibilities are defined in a current job description.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.1.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Individual
staff members who are not licensed to practice independently have their
responsibilities defined in current job descriptions. The job descriptions are
the basis for their assignments, orientation to their work, and evaluation of
how well they fulfil job responsibilities.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Job
descriptions are also needed for health care practitioners when:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l32 level1 lfo42; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
individual serves in primarily a managerial role, such as department manager,
or in dual clinical and managerial roles, with the managerial responsibilities
identified in a job description.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l32 level1 lfo42; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
individual has some clinical responsibilities for which he or she has not been
authorized to practice independently, such as an independent practitioner
learning a new role or new skills;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l32 level1 lfo42; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
individual is in educational program and under supervision, and the academic
program identifies, for each stage or level of training, what can be done
independently and what must be under supervision. The program description can
serve as the job description in such cases; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l32 level1 lfo42; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
individual is permitted to temporarily provide services in the hospital, for
example, a nurse for a temporary staffing agency.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
a hospital uses national or generic job descriptions (for example, a job
description for a “nurse”), it is necessary to augment this type of job
description with specific job responsibilities for the types of nurses (for
example, intensive care nurse, pediatric nurse, or operating theatre nurse,
among others). For those permitted by law and the hospital to practice independently,
there is a process to identify and to authorize the individual to practice
based on education, training, and experience. The requirements of this standard
apply to all types of “staff” who require job description (for example, full
time, part–time, employed, voluntary, or temporary).</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.1.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
staff member not permitted to practice independently has a job description.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Those
individuals identified in (a) through (d) in the intent, when present in the
hospital, have job descriptions appropriate to their activities and
responsibilities or have been privileged if noted as an alternative.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Job
descriptions are current according to hospital policy</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Leaders
of hospital departments and services develop and implement processes for
recruiting, evaluating, and appointing staff as well as other related
procedures identified by the hospital.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides an efficient, coordinated, or centralized process for:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Recruiting individuals for
available positions</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Evaluating the training, skills,
and knowledge of candidates; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Appointing individuals to the
hospital’s staff.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">If
the process is not centralized, similar criteria, processes, and forms result
in a uniform process across the hospital for similar types of staff, for
example, for nurses or physical therapists. Departments/services leaders
participate by recommending the number and qualifications of staff needed to
provide clinical services to patients, as well as nonclinical support
functions, and to fulfil any teaching, research, or other departmental
responsibilities. Department and service leaders also help make decisions about
individuals to be appointed to the staff. Thus, the standards in this chapter
complement the Governance, Leadership, and Direction standards that
describe/service leader’s responsibilities.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital establishes and implements a process to recruit staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital establishes and implements a process to evaluate the qualification of
new staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital establishes and implements a process to appoint individuals to the
staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital establishes and implements a process that is uniform across the
hospital for similar types of staff.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital uses a defined process to ensure that clinical staff knowledge and
skills are consistent with patient needs.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Qualified
staff members are hired by the hospital through a process that matches the
requirements of the position with the qualification of the prospective staff
member. This process also ensures that the staff member’s skill is initially
and over time consistent with the needs of patients.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">For
the hospital’s health care practitioner who are independent practitioners (that
is, they do not practice under job description), the process is identified in
SQE.9 through SQE.12.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">For
clinical staff under job description, the process includes the following:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An initial evaluation to ensure
that he or she can assume those responsibilities in the job description. This
evaluation is carried out before or at the time of starting to perform work
responsibilities. The hospital may have a “probationary” or other period during
which the clinical staff member is closely supervised and evaluated, or the
process may be less formal. Whatever the process, the hospital ensures that
staff providing high–risk services or providing care to high–risk patients are
evaluated at the time they begin providing care, before the probationary or
orientation period is completed. This evaluation of necessary skills, and
knowledge and desired work behaviours, is carried out by the department or
service to which the staff member is assigned.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The hospital then defines the
process for and the frequency of the ongoing evaluation of staff abilities.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Ongoing
evaluation ensures that training occurs when needed and that the staff member can
assume new or changed responsibilities. Although such evaluation is best
carried out in an ongoing manner, there is at least one documented evaluation of
each clinical staff member working under a job description each year.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital uses a defined process to match the clinical staff knowledge, skills
and competency with patient needs.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">New
clinical staff members are evaluated before or at the time they begin their
work responsibilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
department or service to which the individual is assigned conducts the
evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital defines the frequency of ongoing clinical staff evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is at least one documented evaluation of each clinical staff member working
under a job description each year or more frequently as defined by the
hospital.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.4</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital uses a defined process to ensure that nonclinical staff knowledge and
skills are consistent with hospital needs and the requirements of the position.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.4</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital seeks staff that can completely fill the requirements of nonclinical
positions. The supervisor of the nonclinical staff member provides an
orientation to the position and ensures that the worker can fulfil the
responsibilities of the job description. The staff member receives the required
level of supervision and on a periodic basis is evaluated to ensure continuing
competence in the position.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.4</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital uses a defined process to match nonclinical staff knowledge and skills
with the requirements of the position.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">New
nonclinical staff are evaluated before or at the time they begin their work
responsibilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
department or service to which the individual is assigned conducts the
evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital defines the frequency of ongoing nonclinical staff evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is at least one documented evaluation of nonclinical staff members each year or
more frequently as defined by the hospital.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is documented personnel information for each staff member.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">An
accurate personnel file provides documentation of staff knowledge, skill, competency,
and training required for carrying out job responsibilities. In addition, the
record shows evidence of staff performance and whether they are meeting job
expectations. Personnel files may contain sensitive information and thus must
be kept confidential.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
staff member in the hospital, including those permitted by law and the hospital
to work independently, has a record(s) with information about his or her
qualifications; required health information, such as immunization and evidence
of immunity; evidence of participation in orientation as well as ongoing
in–service and continuing education; results of evaluations, including
individual performance of job responsibilities and competencies; and work
history. The records are standardized and kept current according to hospital
policy.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.5</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Personnel
files for each staff member are standardized and current and maintained and
kept confidential according to hospital policy.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Personnel
files contain the qualification and the work history of the staff member.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Personnel
files contain the job description of the staff member when applicable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Personnel
files contain a record of orientation to the hospital and the staff member’s
specific role and in–service education needed by the staff member.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Personnel
files contain the results of performance reviews.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Personnel
files contain required health information.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
staffing strategy for the hospital, developed by the leaders of hospital
departments and services, identifies the number, types, and desired
qualifications of staff.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.6.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
staffing strategy is reviewed on an ongoing basis and updated as necessary.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.6 and SQE.6.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Appropriate
and adequate staffing is critical to patient care as well as to all teaching
and research activities in which the hospital may be engaged. Staff planning is
carried out by department/service leaders. The planning process uses recognized
methods for determining levels of staffing. For example, a patient acuity
system is used to determine the number of licensed nurses with pediatric
intensive care experience to staff a 10–bed pediatric intensive care unit.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
strategy is written and identifies the number and types of required staff and
the skills, knowledge, and other requirements needed in each department and
service. The strategy addresses:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The reassignment of staff from
one department or service to another in response to changing patient needs or
staff shortages;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The consideration of staff
requests for reassignment based on cultural values or religious beliefs; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Compliance with local laws and
regulations</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Planned
and actual staffing is monitored on an ongoing basis, and the strategy is
updated as necessary. There is a coordinated process for the department/service
leaders to update the overall strategy.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.6</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital’s department/service leaders develop a written strategy for staffing
the hospital in a manner the complies with local laws and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
number, types, and desired qualifications of staff are identified in the
strategy using a recognized staffing method.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
strategy addresses the assignment and reassignment of staff.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.6.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
effectiveness of the staffing strategy is monitored on an ongoing basis.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
strategy is revised and updated when necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
strategy is coordinated through a process that involves the department/service
leaders.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.7</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">All
clinical and nonclinical staff members are oriented to the hospital, the
department or unit to which they are assigned, and to their specific job
responsibilities at appointment to the staff.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.7</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
decision to appoint an individual to the staff of a hospital sets several
processes in motion. To perform well, a new staff member, no matter what his or
her employment status, needs to understand the entire hospital and how his or
her specific clinical and nonclinical responsibilities contribute to the
hospital’s mission. This is accomplished through a general orientation to the
hospital and his or her role in the hospital and a specific orientation to the
job responsibilities of his or her position. The orientation includes the
reporting of medical errors, infection prevention and control practices, the
hospital’s policies on telephone medication orders, and so on. Contract
workers, volunteers, and students and trainees are also oriented to the
hospital and their specific assignments or responsibilities, such as patient
safety and infection prevention and control.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.7</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">New
clinical and nonclinical staff members are oriented to the hospital, to the
department or unit to which they are assigned, and to their job
responsibilities and any specific assignments.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Contract
workers are oriented to the hospital, to the department or unit to which they
are assigned, and to their job responsibilities and any specific assignments.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Volunteers
are oriented to the hospital and assigned responsibilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Students
and trainees are oriented to the hospital and assigned responsibilities.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
staff member receives ongoing in–service and other education and training to
maintain or to advance his or her skills and knowledge.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital collects data from several sources to understand its staff’s ongoing
education needs. The results of quality and safety measurement activities are
one source of information to identify staff education needs. Also, monitoring
data from the facility management program, the introduction of new medical
equipment, skill and knowledge areas identified through the review of job
performance, new clinical procedures, and plans to provide new services
represent such sources of data. Also, the hospital determines which staff, such
as health care practitioners, are required to obtain continuing education to
maintain their credentials and how the education of these staff will be
monitored and documented.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">To
maintain acceptable staff performance, to teach new skills, and to provide
training on new medical equipment and procedures, the hospital provides or
arranges for facilities, educators, and time for ongoing in–service and other
education. This education is relevant to each staff member as well as to the
continuing advancement of the hospital in meeting patient needs. For example,
medical staff members may receive education on infection prevention and
control, advances in medical practice, culture of safety, or new medical
equipment. Each staff member’s educational achievements are documented in his
or her personnel record.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospital
leadership supports the commitment to ongoing staff in–service education by
making available space, equipment, and time for education and training
programs. The availability of current scientific information supports the
education and training. The education and training can take place in a
centralized location or in several smaller learning and skill development
locations throughout the facility. The education can be offered once to all or
repeated for staff on a shift–by–shift basis to minimize the impact on patient
care activities.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.8.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
members who provide patient care and other staff identified by the hospital are
trained and can demonstrate appropriate competence in resuscitative techniques.</span></span></p>
<div style="text-align: center;"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="400" src="https://www.youtube.com/embed/n7kqiAu2gC8" title="YouTube video player" width="510"></iframe></div><p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.8.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
hospital identifies those staff to be trained in resuscitative techniques and
the level of training (basic or advanced) appropriate to their roles in the
hospital. The appropriate level of training for those identified is repeated
based on the requirements and/or time frames identified by a recognized
training program, or every two years if a recognized training program is not
used. There is evidence to show if each staff member attending the training achieved
the desired competency level.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.8.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
members who provide patient care and other staff identified by the hospital to
be trained in cardiac life support are identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
appropriate level of training is provided with sufficient frequency to meet
staff needs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is evidence to show if a staff member passed the training.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
desired level of training for everyone is repeated based on the requirements
and/or time frames established by a recognized training program, or every two
years if a recognized training program is not used.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.8.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides a staff health and safety program that addresses staff
physical and mental health and safe working conditions.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.8.2.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital identifies staff who are at risk for exposure to and possible
transmission of vaccine–preventable diseases and implements a staff vaccination
and immunization program.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.8.2 and SQE.8.2.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
hospital’s health and safety program are important to maintain staff physical
and mental health, satisfaction, productivity, and safe condition for work.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">How
a hospital orients and trains staff, provides a safe workplace, maintains
equipment and medical equipment, prevents or controls health–care associated
infections, and many other factors determine the health and well–being of
staff. A staff health and safety program can be located within the hospital or
be integrated into external programs. The program provides for the following:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l46 level1 lfo52; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Initial
employment health screening</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l46 level1 lfo52; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Measures
to control harmful occupational exposures, such as exposure to toxic drugs and
harmful noise levels.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l46 level1 lfo52; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Periodic
preventive immunization and examinations</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l46 level1 lfo52; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Education,
training, and interventions on safe patient handling</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l46 level1 lfo52; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Education,
training and interventions on managing workplace violence.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l46 level1 lfo52; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Education,
training and interventions for staff who may be second victims of adverse or
sentinel events.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l46 level1 lfo52; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Treatment
for common work–related conditions, such as back injuries or more urgent
injuries</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Whatever
the staffing and structure of the program, staff understand how to report, be
treated for, and receive counselling and follow–up for common work–related
injuries such as those that may result from needlesticks, exposure to
infectious diseases, encounters with workplace violence, handling of patients,
hazardous conditions in the facility, and other health safety matters. The
design of the program includes staff input and draws upon the hospital’s
clinical resources as well as those in the community.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Nursing
and other staff who assist with moving patients are at increased risk of back
injuries and other musculoskeletal injuries due to the physical demands of
patient handling. Improper patient handling techniques can also have a negative
impact on patient safety and quality of care. Patient movement and handling
tasks are being done in many different types of clinical settings. Thus, there
is not any one specific solution that is appropriate for all areas in which
patient movement and handling occurs. Examples of safe handling interventions
may include the use of gate belts, lateral transfer aids, training on body
mechanics, implementation of a transfer team and the like.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Violence
in the workplace has become an increasingly common problem in health care
organizations. Staff shortages, increased patient acuity, and the misconception
that violence does not occur in health care organizations – or if violence does
occur, it is part of the job – are just few of the barriers to acknowledging
that workplace violence exists and to developing violence prevention programs.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
caregiving environment often presents emotional challenges that can be mentally
and physically stressful. Health care practitioners are often the second
victims of errors and sentinel events. When patients and their family members
are compromised by clinical errors, the remorse and anxiety felt by caregivers
and their feelings of moral distress are frequently not acknowledged or
addressed. Hospitals need to acknowledge that the emotional health and
performance of health care practitioners involved in adverse and sentinel
events can have an impact on the quality and safety of patient care.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Because
of their contact with patients and patients’ infectious material, many health
care practitioners are at risk of exposure to and possible transmission of
vaccine– preventable diseases. Identifying epidemiologically important
infections, determining staff at high risk for these infections, and
implementing screening and prevention programs (such as immunizations,
vaccinations, and prophylaxis) can significantly reduce the incident of
infectious disease transmission.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Asymptomatic
infections are common, and individuals can be infectious prior to having any
symptoms, including influenza. In addition, studies show that health care
practitioners often report to work even when ill.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospitalized
patients are at significant risk of injury or death from healthcare– associated
infectious disease transmissions. Infectious disease outbreaks in hospitalized
patients have been traced to unvaccinated healthcare practitioners,
particularly in the case of influenza. Hospitals must consider taking steps
toward reducing the risks associated with the transmission of infectious
diseases by unvaccinated healthcare practitioners. Healthcare practitioners
have an ethical and professional obligation to protect themselves, their co-workers,
and patients/families. Vaccination is a duty or all healthcare practitioners.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Strategies
for reducing patients’ risk of exposure to infectious diseases may include
efforts to promote flu vaccination, encouraging staff to get the flu vaccine,
and requiring unvaccinated staff to wear masks during flu season. Unvaccinated
staff providing care to patients who are vulnerable to infection, such as the
immunocompromised, the elderly, and infants, increases the risks to those
patients already at high risk for infection. Therefore, staff immunization
status needs to be considered when making staff assignments.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.8.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides a staff health and safety program that is responsive to
urgent and nonurgent staff needs through direct treatment and referral.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
staff health and safety program include (a) through (g) in the intent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital identifies areas/situations for potential workplace violence and
implements interventions to reduce the risk.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides evaluation, counselling, and follow–up treatment for staff
who are injured because of workplace violence.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital provides education, evaluation, counselling, and follow–up for staff
who are second victims of adverse or sentinel events.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.8.2.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital identifies epidemiologically significant infections, as well as staff
that are at high risk for exposure to and transmission of infections and
implements a staff vaccination and immunization program.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital evaluates the risks associated with unvaccinated staff and identifies
strategies for reducing the patient’s risk of exposure to infectious diseases
from unvaccinated staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
infection prevention and control program guide the evaluation, counselling, and
follow–up of staff exposed to infectious diseases.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.9</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a uniform process for gathering the credential of those medical
staff members permitted to provide patient care without supervision.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.9.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
staff members’ education, licensure/registration, and other credentials
required by law or regulations and the hospital are verified and kept current.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.9.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a uniform, transparent decision process for the initial appointment of
medical staff members.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.9 through SQE.9.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Explanations
of terms and expectations found in these standards are as follows:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l24 level1 lfo55; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Credentials</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Credentials are documents that are
issued by a recognized entity to indicate completion of requirements or the
meeting of eligibility requirements, such as a diploma from a medical school,
specialty training (residency) completion letter or certificate, completion of
the requirements of a medical professional organization, a license to practice,
or recognition of registration with a medical or dental council. These
documents, some of which are required by law or regulation, but some by
hospital policy, must be verified form the original source that issued the
document.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Credentials can also be documents from
individuals and entities that address some aspect of the applicant’s
professional history or competency, such as letters of recommendation, a
history of all previous hospital medical staff appointments, records of
previous clinical care, health history, picture, or police background check,
for example. These documents may be required by hospital policy as part of the
credential–gathering process but are not verified from the source that issued
the document unless required by hospital policy. This requirement for
verification of the credential will vary by the position the applicant is
seeking. For example, for an applicant for leader of a department/clinical
service, the hospital may want to verify information regarding the individual’s
previous administrative positions and experience. Also, for clinical positions,
the hospital may require a certain number of years of experience and thus would
verify this level of experience.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l24 level1 lfo55; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Medical
Staff</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical staff are all Physicians,
Dentists, and other professionals who are licensed to practice independently
(without supervision) and who provide preventive, curative, restorative,
surgical, rehabilitative, or other medical or dental services to patients; or
who provide interpretative services for patients, such as pathology, radiology,
or laboratory services. All classification of appointments, all types, and
levels of staff (employed, honorary, contract, visiting, and private community
staff members), are included. Visiting staff include those who are locum
tenens, or invited experts, “master class” teachers, and others allowed to
provide patient care services temporarily.<span style="mso-spacerun: yes;">
</span>A hospital must define those other practitioners, such as “house
officers,” “hospitalists,” and “junior doctors,” that are no longer in
training, but may or may not be permitted by the hospital to practice
independently. The term medical staff is thus inclusive of all physicians and
other professionals permitted to treat patients with partial or full
independence, regardless of their relationship to the hospital (for example,
employed staff or independent consultants). Note that in some cultures
traditional medicine practitioners, such as acupuncturists, chiropractors, and
others, may be permitted by law and the hospital to practice independently
thus, they are considered medical staff members, and these standards apply in
full.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l24 level1 lfo55; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Verification</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Verification is the process of checking
the validity and completeness of a credential from the source that issued the
credential. This process can be accomplished by an inquiry to a secure online
database of, for example, those individuals licensed in the hospital’s city or
country. The process can also be accomplished by documenting a telephone conversation
with the issuing source, or by sending an e–mail or conventional postal letter
inquiry with the source. Verification of credentials from outside the country
may be more complex and, in some cases, not possible. There should, however, be
evidence of a credible effort to verify the credential. A credible effort is
characterized by multiple (at least within 60 days) attempts by various methods
(for example, phone, email, and letter) with documentation of the attempts and
result(s).</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The three following situations are
acceptable substitutes for hospital performing primary source verification of
credentials:</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l41 level1 lfo56; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Applicable
to hospitals overseen directly by governmental bodies, the government’s
verification process, supported by the availability of published governmental
regulations about primary source verification; plus, government licensure, or
equivalent such as registration; and the granting of specific status (for
example, consultant, specialist, and others) are acceptable. As with all
third–party verification processes, it is important to verify that the third
party (for example, a government agency) implements the verification process as
described in policy or regulations and that the process meets the expectations
described in these standards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l41 level1 lfo56; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Applicable
to all hospitals, an affiliated hospital that has already conducted primary
source verification of the medical staff applicant, is acceptable as along as
the affiliated hospital has current Joint Commission International (JCI)
accreditation with “full compliance” on its verification process found in
SQE.9.1, MEs 1 and 2. Full compliance means the hospital’s Official Survey
Findings Report indicates that all measurable elements are fully met, or any
not met or partially met measurable element required to be addressed by
Strategic Improvement Plan (SIP) actions have been addressed and are now in
full compliance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l41 level1 lfo56; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Applicable
to all hospitals, the credentials have been verified by an independent third
party, such as a designated, official, governmental, or nongovernmental agency,
as long as the following conditions apply: Any hospital that bases its
decisions in part on information from a designated, official, governmental, or
nongovernmental agency should have confidence in the completeness, accuracy, and
timeliness of that information. To achieve this level of confidence in the
information, the hospital should evaluate the agency providing the information
initially and then periodically thereafter to ensure that JCI standards
continue to be met.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">It is important to understand the
process for issuing some credentials. For example, does the government agency
that issues the license to practice base its decision on any or all the
following: verification of education, an examination of competence, training by
a medical specialty association, or membership and payment of fees? Also, if
admission to a specialty education program is based on verification of
education and experience to date, the hospital does not need to verify
education again. The process used by the government agency is documented by the
hospital. If the hospital does not have direct knowledge of the process used by
the agency to verify education, or the hospital has never had an opportunity to
verify that the agency carries out the process as described, then the hospital
need to perform its own verification.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l24 level1 lfo55; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Appointment</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Appointment is the process of reviewing
an initial applicant’s credentials to decide if the individual is qualified to
provide patient care services that the hospital’s patients’ needs, and the
hospital can support with qualified staff and technical capabilities. For
initial applicants, the information reviewed is primarily from outside sources.
Hospital policy identifies the individuals or mechanism accountable for this
review, any criteria used to make decisions, and how decisions will be
documented. Hospital policy identifies the process of appointment of
independent practitioners for emergency needs or a temporary period. For such
individuals, the appointment and identification of privileges are not made
until at minimum licensure has been verified.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l24 level1 lfo55; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Reappointment</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Reappointment is the process of
reviewing the medical staff member’s file to verify:</span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Continued
Licensure</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
the medical staff member is not compromised by disciplinary actions of
licensing and certification agencies;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
the file contains sufficient documentation for seeking new or expanded
privileges or duties in the hospital; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
the medical staff member is physically and mentally able to provide patient
care and treatment without supervision.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The information for this review is from
both internal and external sources. When a clinical departments/service (for
example, a subspecialty service) does not have a leader, there is a hospital
policy that identifies who will do the review of the professionals in that
department/service. The credential file of a medical staff member should be a
dynamic source of information and under constant review. For example, when a
medical staff member presents a certificate of achievement related to an
advanced degree or advanced specialty training, the new credential should be
immediately verified from the issuing source. Similarly, when an outside agency
investigates a sentinel event related to a medical staff member and issues
sanctions, this information should be used promptly to re-evaluate the clinical
privileges of the medical staff member. To ensure that medical staff files are
complete and accurate, the files are reviewed at least every three years, and a
note in the file indicates any actions taken or that no action is necessary and
the appointment to the medical staff continues.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical staff membership may not be
guaranteed if the hospital does not have the special medical equipment or staff
to support the professional practice of the individual. For example, a
nephrologist seeking to provide dialysis services at the hospital, may not be
granted medical staff membership if the hospital does not provide such
services.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Finally, when an applicant’s
licensure/registration has been verified from the issuing source, but other
documents – such as education and training – have yet to be verified, the
individual may be granted medical staff membership, and privileges may be
identified for the applicant for a period not to exceed 90 days. Under such
circumstances, these individuals may not practice independently and require
supervision until all credentials have been verified. Supervision is clearly
defined in hospital policy as to level and condition, and is not to exceed 90
days.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.9</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has an ongoing, uniform process to manage the credentials of medical
staff members.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
staff members permitted by laws, regulations, and the hospital to provide
patient care without supervision are identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Education,
licensure/registration, and other credentials required by law or regulations
are copied by the hospital and maintained for each medical staff member in
their personnel file or in separate credential file.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
credentials required by hospital policy are copied by the hospital and
maintained for each medical staff member in his or her personnel file or in a
separate credential file.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.9.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Education,
licensure/registration, and other credentials required by law or regulation or
issued by recognized education or professional entities as the basis for
clinical privileges are verified from the original source that issued the
credential.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Additional
credentials required by hospital policy are verified from the source that
issued the credential when required by hospital policy.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
third–party verification is used, the hospital verified that the third party
(for example, a government agency) implements the verification process as
described in policy or regulations and that the process meets the expectations
described in the intent.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.9.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
staff appointments are made according to hospital policy and are consistent
with the hospital’s population, mission, and services provided to meet patient
needs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Appointments
are not made until at least licensure/registration has been verified from the
primary source, and the medical staff member then provides patient care services
under supervision until all credentials required by laws and regulations have
been verified from the original source, up to a maximum of 90 days.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
method of supervision, frequency of supervision, and accountable supervisors
are documented in the credential file of the individual.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.11</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital uses an ongoing standardized process to evaluate the quality and
safety of the patient care provided by each medical staff member.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.11</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Explanations
of terms and expectations found in these standards are as follows:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l30 level1 lfo60; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Ongoing
Monitoring and Evaluation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Ongoing monitoring and evaluation
compose the process of continuously accumulating and analyzing data and
information on the behaviors, professional growth, and clinical results of
medical staff members. The department/service leader is responsible for the
integration of the data and information on medical staff and taking appropriate
actions. Immediate actions may be to counsel the staff member, place him or her
under supervision, limit privileges, other measures intended to limit risks to
patients and improve quality of care and patient safety. Long–term actions
include synthesizing the data and information into a recommendation for
continued medical staff membership and clinical privileges. Other actions may
be to note to other medical staff members the benchmark behaviours and clinical
results evident in the data and information of the medical staff member.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The ongoing monitoring and evaluation of
medical staff members provides critical information to the process of
maintaining medical staff membership and to the process of granting clinical
privileges. Although three–year cycles are required for renewing medical staff
membership and clinical privileges, the process is intended to be ongoing and
dynamic. Critical quality and patient safety incidents can arise if a medical
staff member’s clinical performance issues are not communicated and acted on
when they arise.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The process of ongoing monitoring and
evaluation is intended to:</span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Improve
individual practices to high–quality, safe patient care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Provide
the basis for reducing variation within a department/service through
comparisons among colleague and the development of practice guidelines and
clinical protocols; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Provide
the basis for improving the results of the entire department/service through
comparisons with external benchmark practices and published research and
clinical results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The ongoing monitoring and evaluation of
medical staff members encompasses three general areas – behaviors, professional
growth, and clinical results.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l30 level1 lfo60; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Behaviors</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical staff members are models and
mentors in creating a safe culture in a hospital. A safe culture is
characterized by full participation by all staff, without fear of reprisal or
marginalization. Safe cultures also include high respect between professional
groups in which disruptive and other behaviours do not occur. Staff feedback
through surveys and other mechanisms can shape desired behaviours and can
support medical staff role models.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">An evaluation of behaviors can include:</span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Evaluation
of whether a medical staff member understands and supports the hospital’s code
of behavior and the identification of acceptable and unacceptable behavior.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Gathering,
analysis, and use of information and data from staff surveys and other sources
regarding the culture of safety in the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The ongoing monitoring and evaluation
process should indicate, as part of the review process, the relevant achievements,
and challenges of the medical staff member in efforts to be a full participant
in a safe and just culture.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l30 level1 lfo60; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Professional
Growth</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical staff members grown and mature
as the organization in which they practice evolve, introducing new patient
groups, technologies, and clinical science. Each medical staff member, to
varying degrees, will reflect growth and improvement in the following important
dimensions of healthcare and professional practice:</span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Patient
care, including provisions of patient care that is compassionate, appropriate,
appropriate, and effective for health promotion, disease prevention, treatment
of disease, and care at the end of life. (Potential measures include frequency
of preventive services and reports from patients and families.)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical/clinical
knowledge, including knowledge of established and evolving biomedical,
clinical, epidemiologic, and social–behavioural sciences, as well as the
application of knowledge to patient care and the education of others.
(Potential measures include application of clinical practice guidelines,
including the adaptation and revision of guidelines, participation in
professional conferences, and publications.)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Practice–based
learning and improvement, including use of scientific evidence and methods to
investigate, evaluate, and continuously improve patient care based on self–evaluation
and lifelong learning. (Examples of potential measures include self–motivated
clinical inquiry/research, acquiring new clinical privileges based on study and
acquiring new skills, and full participation in meeting requirements of
professional specialty requirements or continuing education requirements of
licensure.)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Interpersonal
and communication skills, including establishment and maintenance of effective
exchange of information and collaboration with patients, their families, and
other members of healthcare teams. (Examples of potential measures include
participation in teaching rounds, team consultations, team leadership, and
patient and family feedback.)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Professionalism,
including commitment to continuous professional development, ethical practice,
an understanding and sensitivity to diversity, and a responsible attitude
toward patients, their profession, and society. (Examples of potential measures
include an opinion leader within the medical staff on clinical and professional
issues, service on an ethics panel or discussions of ethical issues, keeping
appointed schedules, and community participation.)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">System–based
practices, including awareness of and responsiveness to the larger contexts and
systems of healthcare, as well as the ability to call effectively on other
resources in the system to provide optimal healthcare. (Examples of potential
measures include understanding the meaning of frequently used, hospitalwide
systems, such as the medication system; and awareness of the implications of
the overuse and underuse, and misuse of systems).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Stewardship
of resources, including understanding of the need for stewardship of resources
and practicing cost–conscious care, including avoiding the overuse and misuse
of diagnostic tests and therapies that do not benefit patient care but add to
healthcare costs. (Examples of potential measures include participation in key
purchasing decisions within their practice area, participating in efforts to
understand appropriate use of resources, and being aware of the cost to
patients and payers of the services they provide.)</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The ongoing monitoring and evaluation
process should recognize, as part of the review process, the relevant areas of
achievement and potential improvement of the medical staff member in these
professional growth areas.</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l30 level1 lfo60; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Clinical
Results</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The ongoing monitoring and evaluation
process for a medical staff member reviews information common to all medical
staff members as well as specific information related to the clinical
privileges of the member and the services provided by his or her specialty.</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l44 level1 lfo61; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospitalwide
Data Sources</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospital collects a variety of data for
use in management; for example, reporting to health authorities to support
allocation of resources or payment of services. To be useful in the ongoing
evaluation of an individual medical staff member, such as hospitalwide data:</span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Need
to be collected in such a manner that individual practitioners can readily be
identified;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Must
relate to the clinical practice of the individual medical staff member; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Can
be benchmarked internally and/or externally to understand individual
practitioner patterns.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Examples of such potential sources of
data include length of stay, frequency of diagnostic testing, blood usage, and
usage of certain drugs, among others.</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l44 level1 lfo61; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Department–specific
Data Sources</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Data are collected at the level of each
department/service. The department/service leader set the priorities for
measurement in the department for purposes of monitoring as well as
improvement. The measures are specific to the services provided and the clinical
privileges of the individual medical staff members within the department. As
with hospitalwide data, to be useful in the ongoing evaluation of an individual
department/service member, the data:</span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Need
to be collected in a manner such that individual practitioners can readily be
identified;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Must
relate to the clinical practice of the individual medical staff member; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Can
be benchmarked within the department/service and/or externally to understand
individual practitioner patterns.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Examples of such potential
department/service data include frequency of clinical procedures performed,
complications, outcomes, and use of resources such as consultants, among
others.</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Also, it is important to note that it is
not anticipated that any department/service will have the capacity or need to
monitor all the listed privileges of every practitioner. It is more feasible to
collect data on key services or some aspect of key services on the department
level for which all or most department/service staff members have privileges.</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Thus, there is no one set of data that
will suffice to monitor and evaluate all medical staff members. The choice of
data, the frequency of monitoring and analysis, and the actual use of the data
and documentation in the record of the medical staff member are very specific
to the department/service, to the relevant profession, and to the privileges of
the practitioner. The monitoring and evaluation of medical staff members is
supported by a variety of data sources, including electronic and paper records,
observations, and peer interactions.</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">An important final step is to ask
question: “How is this practitioner doing compared to other colleagues within
his or her department and in comparison to professional colleagues in other
hospitals, regions or countries?” The internal comparison is primarily to
reduce variation in practice and outcomes within the department and learn from
the best practices within the department. The external comparison is to ensure
that the hospital achieves best practices within the respective profession.
Each department will have knowledge of those professional databases, clinical
practice guidelines, and scientific literature sources that describe those
desirable benchmark practices. For example, oncology registries can be helpful,
or data from practitioners using the same science (clinical practice
guidelines). Similarly, a national or international surgical society may
collect outcome or complication data.</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">In summary, the ongoing medical staff
monitoring and evaluation process:</span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Is
standardized by type of medical staff member and/or department or clinical
services unit;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Uses
the monitoring data and information for internal comparisons to reduce
variation in behaviors, professional growth, and clinical results;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Uses
the monitoring data and information for external comparisons with available,
objective, evidence–based best practice or benchmark sources of clinical result
data and information;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Is
conducted by the individual’s department or service head, senior medical
manager, or a medical staff review body;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Includes
the monitoring and evaluation of senior medical staff and department heads by
an appropriate professional; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l50 level2 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Provides
information that will be documented in the medical staff member’s file,
including the results of reviews, action taken, and the impact of those actions
on privileges (if any).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt;"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Finally, while the process of monitoring
and evaluation of medical staff members is intended to be ongoing, and data and
information may be accumulated on an ongoing basis, hospital policy requires a
review at least once during a 12–month period. The review is conducted by the
individual’s department or service head, as senior medical manager, or a medical
staff review body. Findings, conclusions, and any actions taken or recommended
are recorded in the medical staff member’s file. When the findings affect the
appointment or privileges of the medical staff member, there is a process to
take action on the findings. Such immediate “for cause” actions are documented
in the practitioner’s file and are reflected in the list of clinical
privileges. Notification is sent to those in which the practitioner provides
services.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.11</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
medical staff members are included in an ongoing professional practice
monitoring and evaluation process as defined by hospital policy and
standardized at the department/service level.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
monitoring and evaluation process identifies areas of achievement and potential
improvement related to the behaviors, professional growth, and clinical results
of the medical staff member compared to other department/service medical staff
members.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
clinical results of data and information available on medical staff members are
reviewed with objective and evidence–based information, as available, for
external benchmarking.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
data and information from the monitoring are reviewed at least every 12 months by
the individual’s department or service head, senior medical manager, or medical
staff body, and the results, conclusions, and any actions taken are documented
in the medical staff member’s credentials file and other relevant files.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
the findings affect the appointment or privileges of the medical staff member,
there is a process to act on the findings, and such “for cause” actions are
documented in the practitioner’s file and are reflected in the list of clinical
privileges. Notification is sent to those sites in which the practitioner
provides services.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.15</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a uniform process to gather, to verify, and to evaluate other
healthcare practitioners’ credentials (license, education, training, and
experience).</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
SQE.15</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospitals
employ or may permit a variety of other healthcare practitioners to provide
care and services to their patients or to participate in patient care
processes. For example, these professionals include nurse practitioners, nurse
midwives, surgical assistants, emergency medical care specialists, pharmacists,
and pharmacy technicians. In some countries or cultures, this group also
includes traditional healers or those who provide alternative services or
services that complement traditional medical practice (for example,
acupuncture, herbal medicine). Often, these individuals do not actually
practice in the hospital; instead, they refer to the hospital or provide
continuing or follow–up care for patients in the community. Many of these
professionals complete formal training programs and receive licenses or
certificates or are registered with local or national authorities. Others may
complete less formal apprentice programs or other supervised experiences.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">For
those other healthcare practitioners permitted to work or to practice in the
hospital, the hospital is responsible for gathering and verifying their
credentials. The hospital must ensure that other healthcare practitioners are
qualified to provide care and treatments and must specify the types of care and
treatment they are permitted to provide if not identified in laws or
regulations. The hospital ensure that other healthcare practitioners are
qualified to provide safe and effective care and treatment to patients by:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Understanding the applicable laws
and regulations that apply to such practitioners;</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Gathering all available
credentials on everyone, including at least evidence of education and training,
evidence of current licensure or certification when required; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Verification of the essential
information, such as current registry, licensure, or certification</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital needs to make every effort to verify essential information relevant to
the individual’s intended responsibilities, even when the education took place
in another country and a significant time ago. Secure websites, documented
phone confirmation form the source, written confirmation, and third parties,
such as a designated, official governmental or nongovernmental agency, can be
used.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
situations described for medical staff in the intent of SQE.9 are acceptable
substitutes for a hospital performing primary source verification for the
credentials or other healthcare practitioners staff.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Standard
compliance requires that primary source verification is carried out for:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">New applicants beginning four
months prior to initial accreditation survey; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Currently employed health
practitioners during a period of three years postsurvey.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">When
there is no required formal education process, licensure, or registry process
or other credential or evidence of competency, this is documented in the
individual’s record. When verification is not possible, such as with the loss
of records in disaster, this is documented in the individual’s record. The
hospital gathers and maintains a file of each healthcare practitioner’s
credentials. The files contain current licenses or registry when regulations
require periodic renewal.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.15</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a standardized process to gather and document the education, certifications,
and experience of each healthcare practitioner.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Education,
training, and certification are verified from the original source according to
the parameters found in the intent of SQE.9 and are documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Licensure
is verified from the original source according to the parameters found in the
intent of SQE.9 and is documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a record maintained on other healthcare practitioners that contains copies
of any required license, certification, or registration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a process to ensure that other staff who are not employees of the
hospital but accompany private physicians and provide services to the
hospital’s patients have valid credentials that are comparable to the
hospital’s requirement for credentials.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.16</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a uniform process to identify job responsibilities and to make
clinical work assignments based on other healthcare practitioners’ credentials
and any regulatory requirements.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
SQE.16.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a uniform process for healthcare practitioners’ participation in
the hospital’s quality improvement activities.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of SQE.16 and SQE.16.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital is responsible for identifying the types of activities or range of
services these individuals will provide in the hospital. This can be
accomplished through agreements, job assignments, job descriptions or other
methods. In addition, the hospital defines the level of supervision (consistent
with existing laws and regulations), if any, for these professionals. Other
healthcare practitioners are included in the hospital’s quality management and
improvement program.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.16</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Licensure,
education, training, and experience of other healthcare practitioners are used
to make clinical work assignments.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
process considers relevant laws and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
process supports the staffing process for other healthcare practitioners.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of SQE.16.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other
healthcare practitioners participate in the hospital’s quality improvement
activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
performance of other healthcare practitioners is reviewed when indicated by the
findings of the quality improvement activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Appropriate
information from the review process is documented in the health care
practitioner’s file.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">MANAGEMENT OF
INFORMATION (MOI) STANDARD</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;"><o:p> </o:p></span></b></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital plans and designs information management process to meet internal and
external information needs.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Information
is generated and used during patient care and for managing a safe and effective
hospital. The ability to capture and to provide information requires effective
planning. Planning incorporates input from a variety of sources, including the
following:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The healthcare practitioners</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The hospital’s managers and
department/service leaders</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Those outside the hospital who
need or require data or information about the hospital’s operation and care
processes</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
planning also includes the hospital’s mission, services provided, resources,
access to affordable technology, and support for effective communication among
caregivers. The priority information needs of these sources influence the
hospital’s information management strategies and ability to implement those
strategies. The strategies meet the needs of the hospital based on the
hospital’s size, complexity of services, availability of trained staff, and
other human and technical resources. The information processes are
comprehensive and include all the departments and services of the hospital.
Planning for the management of information does not require a formal written
information program but does not require evidence of a planned approach that
identifies the hospital’s information needs.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
information needs of those who provide clinical services are considered in the
planning process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
information needs of those who manage the hospital are considered in the
planning process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
information needs and requirements of individuals and agencies outside the
hospital are considered in the planning process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
planning is based on the hospital’s size and complexity.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Information
privacy, confidentiality, and security – including data integrity – are maintained.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital maintains the privacy and confidentiality of data and information and
is particularly careful about preserving the confidentiality of sensitive data
and information. The balance between data sharing and data confidentiality is
addressed. The hospital determines the level of privacy and confidentiality
maintained for different categories of information (for example, patient
information research data, and quality data).</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Maintaining
data integrity is an important aspect of information management. The
information contained in a database must be accurate to ensure that the
interpretation of results from data analysis is meaningful. In addition, data
integrity is maintained during planned and unplanned downtown of data systems.
This is accomplished through implementation of downtime recovery tactics and
ongoing data backup processes.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Policies
and procedures address security procedures that allow only authorized staff to
gain access to data and information. Access to different categories of
information is based on need and defined by job title and function, including
students in academic settings. An effective process defines:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Who has access to data and information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The information to which an
individual has access.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The user’s obligation to keep
information confidential.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The process for maintaining data
integrity; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The process followed when
confidentiality, security, or data integrity are violated.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has written process that protects the confidentiality, security and
integrity of data and information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
process is based on and consistent with laws and regulations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
process identifies the level of confidentiality maintained for different
categories of data and information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Those
persons who need or have a job position permitting access to each category of
data and information are identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Compliance
with the process is monitored, and actions are taken when confidentiality,
security or data integrity are violated.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital determines the retention time of records, data, and information.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital determines the retention time of medical records and other data and
information. Medical records and other data and information are retained for
sufficient periods to comply with laws and regulations and to support patient
care, management, legal documentation, research, and education. The retention
of records, data, and information is consistent with the confidentiality and
security of such information. When the retention period is complete, medical
records and other records, data, and information are destroyed in a manner that
does not compromise confidentiality and security.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital determines the retention time of patient medical records and other
data and information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
retention process provides expected confidentiality and security.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records,
data, and information are destroyed in a manner that does not compromise
confidentiality and security.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
data and information need of those in and outside the hospital are met on a
timely basis in a format that meets user expectations and with the desired
frequency.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
format and methods of disseminating data and information to the intended user
are tailored to meet the user’s expectations. Dissemination strategies include:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Providing only the data and
information the user requests or needs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Formatting the report to aid use
in the decision process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Providing reports with the
frequency needed by the user.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Linking sources of data and information;
and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Providing interpretation or
clarification of data.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.5</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Data
and information dissemination meet user needs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Users
receive data and information on a timely basis.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Users
receive data and information in a format that aids its intended use.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
have access to the data and information needed to carry out their job
responsibilities.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
and information are protected from loss, destruction, tampering and
unauthorized access or use.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
records and other data and information are secure and always protected. For
example, active medical records are kept in areas where only authorized
healthcare practitioners have access, and records are stored in locations where
heat, water, fire, or other damage is not likely to occur. The hospital
implements processes to prevent unauthorized access to electronically stored
information.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.6</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
and information are protected from loss.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
and information are protected from damage or destruction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
and information are protected from tampering and unauthorized access or use.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.7</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Decision
makers and other staff members are educated and trained in the principles of
information use and management.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.7</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Individuals
in the hospital who generate, collect, analyze, and use data and information
are educated and trained to effectively participate in using and managing
information. This education and training enable these individuals to:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Understand security and
confidentiality of data and information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use measurement instruments,
statistical tools, and data analysis methods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Assist in interpreting data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use data and information to help
in decision making;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Educate and support the
participation of patients and families in care processes; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l50 level1 lfo2; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use measures to assess and to
improve care and work processes.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Individuals
are educated and trained according to their responsibilities, job descriptions,
and data and information needs.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
information management process makes it possible to combine information from
various sources and generate reports to support decision making. In particular,
the combination of clinical and managerial information helps department/service
leaders to plan collaboratively. The information management process supports
department/service leaders with integrated longitudinal data and comparative
data.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.7</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Decision
makers and others are provided education on the principles of information use
and management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
education is related to the data and information needs of the individual and
job responsibilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Clinical
and managerial data and information are integrated as needed to support
decision making.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Written
documents, including policies, procedures, and programs, are managed in a
consistent and uniform manner.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.8</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Policies
and procedures are intended to provide uniform knowledge on organizational
clinical and nonclinical functions. A written document guides how all policies,
procedures and programs in the hospital will be developed and controlled. This
guidance document includes the following key components:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l70 level1 lfo72; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Review
and approval of all documents by an authorized person before issue.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l70 level1 lfo72; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
process and frequency of review and continued approval of documents.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l70 level1 lfo72; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
control for ensuring that only current, relevant versions of documents are
available.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l70 level1 lfo72; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">How
changes in a document can be identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l70 level1 lfo72; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
maintenance of document identity and legibility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l70 level1 lfo72; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
process for managing documents that originated outside the hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l70 level1 lfo72; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Retention
of obsolete documents for at least the time required by law and regulations,
while ensuring that they will not be mistakenly used.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
tracking system allows each document to be identified by title, date of issue,
edition and/or current revision date, number of pages, who authorized issue
and/or reviewed the document, and database identification (if applicable). The
tracking system helps staff quickly locate a policy relevant to their
assignment or a particular situation. For example, staff in the emergency
department can quickly locate the policy on informed consent when an
unaccompanied minor requires a surgical procedure.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">These
processes for developing and maintaining policies, procedures, and programs are
implemented.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.8</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a written guidance document that defines the requirements for developing and
maintaining policies, procedures, and programs, including at least items (a)
through (g) in the intent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
are standardized formats for all similar documents, for example, all policies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
policies, procedures, and other written documents in circulation are identified
and tracked.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
requirements of the guidance document are implemented and evident in the
policies, procedures, and programs found throughout the hospital.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MOI.8.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
policies, procedures, plans, and other documents that guide consistent and
uniform clinical and nonclinical processes and practices are fully implemented.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MOI.8.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Throughout
the accreditation standards found in this manual, policies, procedures, plans
and other written documents are required. These documents are required, as they
reduce process variation and reduce the risk inherent in processes. This is
particularly important in clinical processes to improve quality and patient
safety.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a process to ensure that staff members have read and are familiar with
policies, procedures, and plans relevant to their work. This process may be
part of the orientation of staff members to their department and their
responsibilities, or may be part of groupwide or hospitalwide special training
sessions. Most importantly, when a policy, procedure, or plan is relevant to
the assignment of an individual, the intended actions described in the document
are evident in the actions of the individual.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MOI.8.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Required
policies, procedures, and plans are available, and staff understand how to
access those documents relevant to their responsibilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
are trained and understand those documents relevant to their responsibilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
requirements of the policies and procedures, and plants are fully implemented
and evident in the actions of individual staff members.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
implementation of policies, procedures, and plans is monitored, and the
information supports full implementation.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">MEDICAL
PROFESSIONAL EDUCATION (MPE) STANDARDS</span></b></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MPE.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital’s governing body and leadership of the hospital approve and monitor
the participation of the hospital in providing medical education.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MPE.1</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Integrating
education of medical students and trainees into a hospital’s operations
requires a significant commitment of time, energy, and resources. Trainees
include interns, residents, house officers, and fellows. Decisions on the
integration of education and operations are best made at the highest decision–making
level of the hospital. When the decision to provide medical education involves
a network or consortia of organization, the governing entity is fully informed
as to all the relationships and accountabilities. As the governing entity level
also is responsible for decisions related to the hospital’s mission, strategic
plans, resource allocation, and quality program, it is necessary to make this
an integrated decision. For example, is the commitment to educate medical
students and trainees consistent with the hospital’s mission, and how will this
commitment be portrayed to the public and the hospital’s patients?</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
governing entity and leadership of the hospital are also responsible for
obtaining, reviewing, and agreeing to the education program parameters of the
sponsoring academic program.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">A
set of metrics, relevant to the education programs within the hospital, is
selected and reported to the governing entity and hospital leadership on an
annual basis for a review of the scope and activities of the program,
achievement of program goals, any relevant regulatory compliance issues, and
the satisfaction of patients and staff with the program.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MPE.1</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
decision to provide medical education is made by the governing entity and
leadership of the hospital, is consistent with the hospital’s mission, and is
documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital’s governing entity and leadership obtain, review, and accept the
parameters of the participating medical school, and this action is documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital’s governing entity and leadership endorse a set of metrics to monitor
and evaluate the ongoing operation of medical education programs, and there is
documented review of the monitoring data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital’s governing entity and leadership review, at least annually, the
medical education programs within the hospital, and the review is documented.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
review includes the satisfaction of patients and staff with the clinical care
provided under the program.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MPE.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital’s clinical staff, patient population, technology, and facility are
consistent with the goals and objectives of the education program.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MPE.2</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Providing
a rich and meaningful learning experience for medical students and trainees
requires many factors, in addition to the governing entity and hospital
leadership commitment. The clinical staff of the hospital must be adequate in
number and in expertise to advance medical student and trainee education. For example,
nursing staff numbers support the educational program, and nursing staff
understand their relationship to the educational program.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital’s patient population is sufficient in number and needs to support the
education and clinical learning experience. There must be adequate classroom
space, off–duty study and rest facilities, and print and online resources to
support an effective learning environment. In addition, adequate opportunities
and time for learning and interactions with clinical staff must be provided.
Contemporary technology needs to be available so that evidence–based health
care practices can be taught.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MPE.2</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is evidence that the clinical staff of the hospital are in adequate number and
have the education, training, and competence to support and advance the
education of medical students and trainees.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is evidence that the hospital’s patient population is adequate in number and
clinical needs to support the education of medical students and trainees.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is evidence that the hospital’s facilities, technology, and other resources
support the education of medical students and trainees.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MPE.3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Clinical
teaching staff are identified, and each staff member’s role and relationship to
the academic institution is defined.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MPE. 3</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Those
clinical staff who have responsibility for medical student and trainee
education and supervision are clearly identified so that the medical students
and trainees and other hospital staff understand educational accountabilities
and authority. For example, when any hospital staff member has a comment,
concern, or other matter related to the educational program or medical students
and trainees, he or she will understand who is accountable for receiving and
acting on that information.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
relationship of the clinical teaching staff of the hospital to the sponsoring
academic institution(s) needs to be clear. For example, when academic titles
are conferred on clinical staff members, it is clear if titles are earned or
honorary, how those titles are to be used, and what the titles mean to the
public. The hospital has a complete listing of clinical teaching staff with
their medical and academic titles. Any requirements for the renewal or
redesignation of academic titles are monitored for compliance.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MPE.3</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Clinical
teaching staff are identified to hospital staff, and there is a complete list
of clinical teaching staff, including both professional and academic titles.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
are educated about these individuals, their accountabilities, and their
authority.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has a process in place to monitor academic titles and requirements for
renewal or redesignation and to keep such titles up to date.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MPE.4</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital understands and provides the required frequency and intensity of
medical supervision for each type and level of medical student and trainee.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MPE.4</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Supervision
is required to ensure safe patient care and ensure that the training program is
a learning experience for the medical student and trainee. The required level
of supervision is consistent with the level of training within the specialty
and level of competence of the medical student and trainee. The hospital
understands that medical student and trainee competence cannot be assumed and
must be demonstrated early in the training program.</span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each
medical student and trainee understand the clinical supervision process,
including who is to provide the supervision and the frequency of the
supervision. For example, a medical student understands whether supervision is
provided by a resident or by the patient’s primary physician or by a medical
school faculty member. Medical students and trainees also understand whether
the supervision includes daily signing of all notes and orders, signing of the
care plan and progress notes every other day, or making a separate entry in the
patient’s medical record. Likewise, it is clear as to how the evidence of that
supervision is documented, including the frequency and location of the
documentation. Finally, to ensure a uniform learning experience, the hospital
has identified and monitors the uniform expectations for the
mentoring/supervision process.</span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MPE.4</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospital
policy identifies and provides the required level of supervision within the
specialty for each level of medical student and trainee.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
level to be provided is based on the demonstrated competency of the medical
student and trainee.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Each
medical student and trainee understand the level, frequency, and documentation
of his or her supervision.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a uniform process for documenting the required supervision that is
consistent with hospital policy, program goals, and the quality and safety of
patient care.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
hospital has established uniform expectations for all staff providing
supervision to ensure that the process results in uniform medical student and
trainee experiences.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
records are reviewed for compliance with the documentation requirements and
frequency.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MPE.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
education provided in the hospital is coordinated and managed through a defined
operational mechanism and management structure.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MPE.5</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
education programs in hospitals require an effective management structure and a
commitment of staff time for their coordination and daily operation. The
agreements between the hospital and the medical school need to be established
and then monitored. There is an accurate list of all medical students and
trainees in the hospital. For each medical student and trainee, there is a
documentation of:</span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l17 level1 lfo79; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Enrolment
status.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l17 level1 lfo79; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Academic
classification.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l17 level1 lfo79; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any
required licensure or certification.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l17 level1 lfo79; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reports
of medical student and trainee achievements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l17 level1 lfo79; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Identification
of medical student and trainee competencies.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l17 level1 lfo79; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any
known factors that will require accommodation; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l17 level1 lfo79; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any
known factors that may influence the level of supervision required.</span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">The
documentation of (a) through (g) for a medical student may be limited depending
on their enrolment status and current level of training. When an academic
program is sponsored by the hospital, it is determined how and where these
activities are conducted.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MPE.5</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
operational structure for medical education in the hospital has been determined
and is in operation as required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
management structure for medical education in the hospital has been determined
and is in operation as required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
is a complete and current list of all medical students and trainees in the
hospital.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">For
each medical student and trainee, there is documentation of at least (a)
through (g) of the intent.</span></span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Standard
MPE.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
students and trainees comply with all hospital policies and procedures, and all
care is provided within the quality and patient safety parameters of the hospital.</span></p>
<p class="MsoNoSpacing"><b><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 14pt;">Intent
of MPE.6</span></b></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Training
program and their students are a critical factor in overall quality of care and
patient safety. Although it would be desirable for each medical student and
trainee to have basic education on quality and patient safety in his or her
respective academic program, this rarely happens. Thus, the hospital must have
a planned and deliberate program to introduce such concepts, support the
medical students and trainees in complying with relevant policies and
guidelines, and include medical students and trainees in all quality and safety
monitoring programs. For example, medical students and trainees would be
educated to comply with the International Patient Safety Goals.</span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Also,
required clinical practice guidelines, surgical time–out procedures, medication
–ordering policies, and other mechanism to reduce variation in care processes –
and thus reduce the risk in those processes – are part of all medical students’
and trainees’ initial orientation and ongoing training and monitoring. The
orientation for the medical student and trainee includes at least:</span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l23 level1 lfo81; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Hospital
quality and patient safety program</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l23 level1 lfo81; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Infection
control program</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l23 level1 lfo81; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medication
safety program</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l23 level1 lfo81; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">International
Patient Safety Goals</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l23 level1 lfo81; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
other required hospital orientation, including at the department and unit level
and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l23 level1 lfo81; text-indent: -18pt;"><span style="color: #01ffff;"><!--[if !supportLists]--><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any
ongoing required education</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-family: "Palatino Linotype",serif; font-size: 12pt;">Those
persons providing medical student and trainee supervision ensure that all
medical students and trainees are knowledgeable about these quality and safety
programs and are included in the monitoring process.</span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="color: #fcff01; font-family: "Palatino Linotype",serif; font-size: 14pt;">Measurable
Elements of MPE.6</span></b></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
medical students and trainees are provided an orientation that includes at
least (a) through (f) of the intent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
students and trainees are included in the data collection for the hospital’s
quality monitoring programs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Those
supervising medical students and trainees ensure that the medical students and
trainees are knowledgeable of the programs and participate in the programs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Medical
students and trainees can demonstrate knowledge of these programs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l18 level1 lfo83; text-indent: -18pt;"><span style="color: #fcff01;"><!--[if !supportLists]--><span style="font-family: Wingdings; font-size: 16pt; mso-bidi-font-family: Wingdings; mso-bidi-font-weight: bold; mso-fareast-font-family: Wingdings;"><span style="mso-list: Ignore;">þ<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Those
supervising medical students and trainees consider compliance with these
programs in their evaluation of medical student and trainee performance.</span></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-12933716749893066362023-03-05T19:41:00.002+08:002023-03-05T19:50:48.822+08:00ISO 17025<p><span style="color: #01ffff; font-size: medium;"> <b style="text-indent: -18pt;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";">1.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-weight: normal; line-height: normal;"> </span></span></b><span dir="LTR" style="text-indent: -18pt;"></span><b style="text-indent: -18pt;"><span style="font-family: "Palatino Linotype",serif;">Introduction</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span><b style="text-indent: -18pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";">1.1<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; font-weight: normal; line-height: normal;"> </span></span></b><span dir="LTR" style="text-indent: -18pt;"></span><b style="text-indent: -18pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">History
and status of ISO 17025:2005</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><span style="color: #01ffff;">Prior to the issuing of ISO 17025:1999
there was no internationally accepted standard for laboratory quality systems
that could provide a globally accepted bases for accreditation. Accreditation
was based on national standards. However, there was considerable level of
uniformity between the requirements expressed in these various standards due to
the existence of ISO Guide 25, a document drawn up by the ISO Council Committee
on Conformity Assessment (CASCO) in response to a request by the International
Laboratory Accreditation Cooperation (ILAC) held in Auckland, New Zealand, in
October 1998.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;">The declared purpose of ISO Guide 25,
taken from its foreword, is to establish the principle that “third party
certification systems (for laboratories) should, to the extent possible, be
based on internationally agreed standards and procedures.” ISO guides are
intended to be used by local standards institutions when preparing their own
national standards. By this means, it is hoped to achieve a high degree of
compatibility between standards prepared in different countries “so as to
facilitate bilateral and multilateral agreements.” (Quotations from the
foreword to ISO Guide 25, 3</span><sup style="font-family: "Palatino Linotype", serif;">rd</sup><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> Edition).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><span style="color: #01ffff;">The document now known as ISO 17025
began life as a revision of the third edition of ISO Guide 25, but during the
revision process it was decided to convert the guide to a standard, so
providing a truly global basis for accreditation. It was also decided to introduce
as much compatibility as possible between ISO 17025 and the generic quality
management system standard ISO 9001, which was also under revision at the same
time. The objective appears to have been to create a logical connection between
ISO 9001 and ISO 17025 such that the former would be seen as a master standard
with ISO 17025 being a specific application of that standard to testing and
calibration laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17023:1999 was accepted by ISO
subscribing countries in late 1999 and came into effective use during the first
quarter of 2000 after its adoption as a national standard by most countries
around the world. The new version of ISO 9001, the 2000 edition, was accepted later.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><span style="color: #01ffff;">The exercise intended to harmonize ISO
17025 and ISO 9001 was, in the event, regarded as imperfect, especially in that
ISO 9001 placed great emphasis on continual improvement in the quality system.
Although this was included in ISO 17025, its importance as a part of the
standard was not strongly emphasized. Hence a revision of ISO 17025 was undertaken,
and this led to ISO 17025:2005 which was adopted as an ISO standard in late May
of 2005.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><span style="color: #01ffff;">There a no fundamental differences
between ISO 17025:1999 and ISO 17025:2005 and nothing which impinges
essentially on the technical requirements. The main differences can be summed
up as follows:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span><span style="font-family: Symbol; font-size: 12pt; text-indent: -18pt;">·<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><span dir="LTR" style="text-indent: -18pt;"></span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt; text-indent: -18pt;">Insistence on a demonstrated
commitment to continually improve the quality management system and identified
mechanisms for achieving this.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; text-indent: -18pt;">·<span style="font-family: "Times New Roman"; font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><span dir="LTR" style="text-indent: -18pt;"></span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt; text-indent: -18pt;">Greater emphasis of the need to
communicate with customers and, especially, to actively solicit feedback on
service quality and ensure the resulting information is used as the basis of
action to improve the management system.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;">The transitional period between ISO
17025:1999 and ISO 17025:2005 lasted two years, with the two standards running
together. In May 2007 ISO 17025:1999 became defunct and existing laboratories
who had not been assessed against the 2005 version ceased to be accredited.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">International
Recognition of Accreditation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Accreditation of laboratories is
generally performed by national accreditation bodies. The primary function of
such bodies is, of course, to provide assessment of laboratories in their
respective countries against ISO 17025. However, they will also often respond
to requests to carry out assessments in other countries, especially if the
requesting laboratory is in a country without its own national accreditation
body. Where there is a national accreditation body in the country and a
laboratory seeks to use a body from another country, the incoming accreditation
body will normally, as a matter or courtesy, seek approval from the resident
body before operating in the country.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A laboratory may prefer to use an
accreditation body other than its domestic organization when the latter has
either no international recognition or where it lacks recognition in parts of
the world relevant to the laboratory’s operations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">International recognition of accreditation
awarded by national bodies is based on the conclusion of Mutual Recognition
Agreements (MRAs) between national bodies. The mechanism is that the bodies
seeking to agree to recognize each other’s accreditations will audit each
other’s operations against ISO 17011: Conformity Assessment – General
requirements for accreditation bodies accrediting conformity assessment bodies.
This is the international standard to which assessment bodies are expected to
adhere.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">MRAs may be multilateral (i.e.,
involving more than two bodies) but even so they can be rather cumbersome, and
it can take many years for a new national body to establish significant
international recognition. However, this rather cumbersome process is being
rapidly streamlined by means of regional laboratory accreditation conferences
linked through ILAC (see section 1.1). the regional body applies rules for
membership, including compliance with ISO 17011, and audits national bodies for
compliance. Mutual recognition is then organized between the regional bodies,
so simplifying the whole system and shortening the timescale.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Key regional groupings are the Asia
Pacific Accreditation Cooperation (APLAC), the European Cooperation for
Accreditation of Laboratories (EAL) and the Southern Africa Development
Community in Accreditation (SADCA).</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This regionalization of international
recognition is developing rapidly but has not been fully established, and it is
still possible to find accreditation bodies who are members of the regional
groups who prefer to pick and choose which of the other members they will
recognize.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In this context of national
accreditation bodies, and mutual recognition it must be noted that not all
countries choose to establish their own domestic accreditation service. In the
case of smaller countries with only limited number of laboratories, this may
make little economic sense. In such instances the country uses other national
bodies, either based on an agreement with a particular body to provide the
service to the country or on an ad hoc basic where each laboratory chooses its
own accreditation service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Currently, attempts are being made to
develop arrangements where several countries club together to have a single
regional accreditation body. It seems likely that initiatives of this type will
bear fruit in Southern Africa.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The recent World Trade Organization
initiatives to deal with technical barriers to trade sought to address the
question of global acceptance of test data as part of quality issues in
international trade. The agreement can be summarized as a recognition that,
when deciding whether data from a particular laboratory is acceptable, a key
criterion should be compliance of the laboratory with ISO 17025. This has been
widely interpreted as meaning that countries all need to establish a national
ISO 17025 accreditation body for laboratories. However, in this context, the
following points need to be noted:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Accreditation must have
credibility, which means, in practice that the accreditation body must apply
ISO 17025 rigorously and itself operate to ISO 17011. Simply having an
accreditation body is not a solution.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The credibility of the
accreditation body on an international scale needs MRAs, especially with
countries which are recipients of a trade goods needing testing support.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The credibility of individual
laboratories can be established by their direct assessment by either customers
or accreditation bodies from trading partners. A national accreditation body is
not essential.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Selection
of a suitable accreditation body by laboratories</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">As should be clear from the foregoing
discussion, the key issue in selecting an accreditation body is to ensure that
it has recognition in the context in which the laboratory’s data need to be
used. Where a laboratory operates purely in a domestic market and where the
data is used only within the country, for example for local food safety or
environmental protection, then a national accreditation body, even one with no
international recognition, will normally be entirely suitable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">However, if the laboratory is servicing
exporters who need to present its data internationally, it is critical that the
accreditation body is recognized by importing countries. Hence the laboratory
needs to establish the range of MRAs held by the accreditation body and
especially which other countries, other than the home country of the
accreditation body, will recognize accreditation awarded by it.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Scope
of Accreditation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Although ISO 17025 is written as though
all the methods used by a laboratory are covered by the standard and hence
included in any accreditation against the standard, this is rarely the case. In
practice, any laboratory will have only some of its methods accredited and
perhaps not even the majority. Despite this, an accreditation body will often
make a formal statement to the effect that it expects to see comprehensively
operating quality system. However, any assessment will focus on the scope of
methods and on the equipment used to deliver them and take little interest
outside this scope. In this sense the term, “accredited laboratory” is
inaccurate. We should rather talk of a laboratory accredited for a specific
list of methods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory will need to select
methods to offer as part of the scope when it makes its application for
accreditation. The following criteria should be born in mind:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Methods which are performed
infrequently, for example <b>less than 12 times per annum</b>, are difficult to
accredit since it is impossible to demonstrate a track record of performance.
If such methods must be included in the accreditation, a large level of quality
control will be required by the assessors.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Methods with little objective
content are unlikely to be able to be accredited since consistency in
application cannot be guaranteed.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Commercial laboratories should
select methods on a purely commercial basis. If there is no commercial
advantage in accreditation of the method, then the cost and effort may not
provide a return.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">In many countries data generated
for environmental, food safety or legal reasons must be covered by
accreditation to be acceptable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Overall, the laboratory should select a
scope of methods which includes those it performs routinely and those where
either commercial or legal issues make accreditation advantageous.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Accreditation bodies differ in precisely
how they define scope, and some will allow a more generic definition in some
area of activity. In such instances they will assess the laboratory for a
particular application of a method plus a procedure to be followed when
extending the method to other areas. For example, a laboratory may have
accreditation or trace metals in certain types of foods with a procedure for
how the recovery checks will be done and evaluated if the method is applied to
a hitherto untried matrix.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Relationship
between ISO 17025 and ISO 9001</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">As discussed above ISO 9001 is the
general standard which specifies the requirements for a quality management
system. Laboratories which meet the requirements of ISO 17025 also operate in
accordance with the requirements of ISO 9001 that are relevant to calibration
and testing activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">What this means in practice is that an
organization which holds ISO 9001 certification may use a laboratory accredited
against ISO 17025 as a supplier of test data without the need to carry out its
own audit of the laboratory’s quality system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The question often arises of whether
laboratories should be accredited/certified to ISO 9001 or to ISO 17025. In
general, it is agreed that the appropriate accreditation for commercial testing
and calibration laboratories is to ISO 17025. As a result of agreements with
laboratory accreditation bodies may ISO 9001 certification bodies will not
allow their certification to be cited for commercial testing or calibration
laboratories in support of their services.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">What this means is that it you are an
ISO 9001 certified organization with in–house laboratory which forms part of
your quality control system, the laboratory will be included in the ISO 9001
external audit. However, if you then want to sell the services of that
laboratory to outsiders as a testing service you cannot advertise it as an ISO
9001 accredited/certified laboratory. You would need to obtain accreditation to
ISO 17025.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is not uncommon, however, for
organization with laboratories used purely for internal quality control
purposes to seek to accredit the laboratory to ISO 17025. This is generally
done to enhance the laboratories, and hence the overall quality control systems,
credibility or as part of the application of an ISO 9001–compliant system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 9001 external auditors will not
usually do a detailed audit of such an internal laboratory if it holds a
current ISO 17025 compliant accreditation. The quality system in the laboratory
is largely taken for granted for ISO 9001 purposes. Since laboratory
accreditation procedures leading to ISO 17025 accreditation are explicitly
designed for laboratories, they can be easier to interpret for the laboratory
as opposed to the rather more diffuse requirements of ISO 9001, which are
designed for a more general context. The other advantage of accrediting an
internal quality control laboratory is that it will generally reduce the number
of audits by customers, and this is often a key reason for seeking
accreditation. Frequent audits by a range of customers can be disruptive to
operations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There are certainly a few significant
omissions from ISO 9001 as compared to ISO 17025 although, as already
discussed, there is a general ISO move to bring the standards closer together.
The additional requirements in ISO 17025, as opposed to ISO 9001, include
participation in Proficiency Testing, adherence to documented, validated,
methodology and specification of technical competence, especially on the part
of senior laboratory personnel. There is also a difference in the method of
scrutiny of laboratories under ISO 9001 as compared to ISO 17025 assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 assessment bodies will always
use technical assessors who are specialists and who carry out a peer review of
the methods being used by the laboratory and the way in which those methods are
applied. An ISO 9001 external audit to determine suitability for certification
does not include this peer review of technical aspects and the auditors are not
required to be technical specialists. They confine their attention to the
quality management system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">From the point of view of a laboratory’s
clients, laboratories meeting the requirements of ISO 17025 fulfil all the
relevant requirements of ISO 9001 when acting as subcontractors. The practical
effect of this is that if an organization which is certified to ISO 9001 is
using an ISO 17025 accredited laboratory as a subcontractor, it can treat it as
an ISO 9001 certified subcontractor for any work within the laboratory’s scope
of ISO 17025 accreditation. There will, for example, be no necessity to carry out
quality audits of the subcontractors.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Summary</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The general view to be taken of these
various guides and standards is that ISO 9001 is the overall standard for
quality management systems and ISO 17025 provides specific guidance on the
application of the ISO 9001 principles to laboratories. This correspondence is
becoming increasingly apparent with the development of both standards,
especially as the language and terminology is converging. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">When seeking to select or establish an
accreditation body for laboratories, the key standard is ISO 17011 which is the
basis on which international acceptance of an accreditation body, and hence its
client laboratories, I achieved. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Organization
and Management</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">General
Points</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is extremely unlikely that any
properly constituted laboratory will need to change its management structure in
any fundamental way to comply with the requirements of ISO 17025. The
management system will, however, must be formally described in the quality
manual and shown on an organization chart. In the case of each level of
management or individual post, there must be job descriptions to describe the
responsibilities to be discharged and the authority given, plus the supervisory
responsibilities of each grade. The usual practice is to include key job
descriptions in the quality manual, for example Laboratory Manager (or
equivalent), Quality Manager or senior staff with specific responsibilities,
but to retain other job descriptions in a separate file or in staffed record
files.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Be sure that responsibilities and
authority match each other at all levels. There is no point in stating that
someone has the responsibility for organizing interlaboratory calibrations, for
example if they do not have the authority to require staff to do the necessary
work and to sanction appropriate expenditure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The following sections give guidance on
the important points to be considered when defining the management structure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Legal
identity of Laboratory</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">You will need to describe the precise
status of the laboratory. Typical examples might be:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An independent commercial testing
laboratory carrying out measurements for clients in return for a fee.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A laboratory which serves a
regulatory authority and provides data to that authority for enforcement
purposes.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A laboratory which is part of a
bigger organization, and which provides an internal service solely within an
organization.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The latter would include company quality
assurance laboratories and laboratories providing in–house environmental
control compliance monitoring.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">You will have to prepare what you feel
is a correct description of your laboratory. The description should also
include a statement of the ownership of the laboratory and its relationship to
any parent or subsidiary organizations. This relationship should be shown on a
chart.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 includes an explicit
requirement that, where the laboratory is part of an organization which
performs activities other than testing and/or calibration, the responsibilities
of all staff in the organization who have influence on the testing/calibration
work are defined to identify potential conflicts of interest. This clause seeks
to ensure that the organization thinks very clearly about any potential
conflicts of interest, and presumable, seeks to minimise or eradicate them. A
clear definition of authority and responsibilities in the quality manual can
certainly contribute here. The sort of policy statement necessary would be one
which places a responsibility on the laboratory to generate and report data
objectively. This would then back up by a statement that no staff have
authority to take any action to require any action to be taken which interferes
with the laboratory in discharging this responsibility, irrespective of the
normal line of management. Since the quality manual is endorsed from the
highest level in the organization, the laboratory staff may then rely upon this
stated policy to protect them from any undue influences.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Body
allocating resources.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In your description of the management structure,
it is essential that you identify the body in the organization which makes
decisions on policy and allocate resources. This will normally be the Board of
Directors or an equivalent body with financial control.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This body must endorse the quality
policy statement which appears in the quality manual and must express a
commitment to the provision of resources to implement and maintain the quality
system. The quality policy and the quality manual should normally be issued on
the authority of the Chief Executive of the organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Technical
Management</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is no requirement in ISO 17025 to
identify a specific technical manager, but the technical management structure must
be specified. This must make clear who is responsible for technical management
and the scope of the responsibilities. For example, if different areas have
different managers, this needs to be specified and their range of
responsibility clearly defined. It is generally expected that in any specific
laboratory there will be a distinct Laboratory Manager, but in larger
organizations with several technically distinct laboratories there may be
several Laboratory Managers with specific technical briefs and with no overall
defined Technical Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Technical Manager must be clearly
distinct from the role of the Quality Manager and the quality management
structure, but the technical management still has an obligation to ensure that
technical activities are conducted in accordance with the requirements of the
quality system. As discussed in Section 2.5, although the Quality Manager has
overall responsibility for quality, this is discharged through monitoring and
advising and not by managing quality control and assurance of technical
activities directly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The description of the technical management
structure must also make clear how supervision arrangement work. Typical
laboratory structure includes technical staff and professional staff. The
general division of labour is that professional staff have responsibility for
method selection, for development of new methods and for interpretation of
data, whereas the actual bench work is done by technical staff, although
professional staff may also be involved. Overall, the professional staff are
responsible for the ultimate quality of the data so the structure must show how
they discharge this responsibility by supervision of the technical staff. This
does not necessarily mean direct supervision but will typically involve
explaining how instructions are passed own to the bench and how data is passed back
and checked.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A key component of this responsibility
is likely to come with the involvement of professional staff in interaction
with customers of the laboratory through the process of review of requests, contracts,
and tenders – see Section 7.3.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Manager</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is the only post required to be
defined by ISO 17025. You do not have to use the actual title, but you must
identify the person responsible for the functions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager is responsible for
implementing and operating the quality system on a day–to–day basis. He or she
is normally responsible for administering the controlled document system, for
compiling the quality manual and for organizing the review and audit of the
Quality system – see Section 4.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Much of the work required of the Quality
Manager is administrative in nature but he or she is also, in the last
analysis, responsible for the effective enforcement of the quality policy. He
or she is also expected to advise management on quality issues by virtue of his
or her close familiarity with the standard and the organization’s quality
management system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager must have direct
access to the highest level of management in the organization, i.e., the body
in Section 2.3 above, and to the Laboratory Technical management. An accreditation
body will generally regard the Quality Manager as the person who provides
day–to–day guardianship of the quality standard and so represents their
interests within the organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The post of Quality Manager may be
filled in several ways depending upon the organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.5.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Full
time Quality Manager</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Few laboratories can support full time
Quality Manager, and it is doubtful whether the post requires the full-time
commitment of one person in laboratories with fewer than 100 staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In large organizations which have
several quality systems running, for example ISO 17025 and ISO 9001, it may be
relevant to have an overall Quality Manager covering all systems, in which case
a full time Quality Manager may make sense. This can work well but only if the
Quality Manager has some laboratory background. Although, in theory, managing
the quality system does not need technical expertise, in practice it is very
difficult for a Quality Manager with no relevant technical insight to operate
with laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">One system which can be effective is to
have an overall, possibly full time, Quality Manager plus quality
representative at laboratory level. These can be individuals who are involved
in laboratory management but who are given a specific brief to manage quality.
They provide local quality expertise and administrative support to the quality
system and assist the Quality Manager. Clearly, in this arrangement the quality
representatives may have dual reporting line: the normal lines to the
Laboratory Manager on technical issues and a line to the Quality Manager on
quality issues.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.5.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Using
a Senior Scientist as Quality Manager</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This type of structure would use one of
the Senior Staff from the tier below that of Laboratory Manager to manage the
quality system. This, of course, means that the Quality Manager occupies a line
management position below that of Laboratory Manager. This should represent no
problems if it is stated in the documentation that, on matters of quality, the
Quality Manager has direct access to the level of management described in
Section 2.3 above. This then provides the Quality Manager with a line of action
in the unlikely event that the Laboratory Manager is contravening the quality
policy and attempts to subvert the Quality Manager by using the line management
authority.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This type of structure operates
effectively in many organizations and is probably the commonest scenario found
in medium sized laboratories. There is often some initial discomfort with such
an arrangement in highly hierarchical organizations but is usually found to be
workable in practice.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.5.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other
possibilities for Quality Manager</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Alternatives to the scenarios already discussed
include the use of a staff member who is not involved in the laboratory work
but who has the necessary technical background. Such person is typically found
amongst individuals who have been promoted into managerial posts from the
laboratory. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><span style="color: #01ffff;">The senior management tier described in
Section 2.3 may contain such individuals. The use of such a person not only
provides an independent form of quality management but underlines the
commitment of the highest level of management of quality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;">In small organization it may be
difficult to separate the quality management and technical management functions
completely, and some laboratory mangers may function as their own Quality
Managers. This is not disallowed by the standard so long as the
responsibilities are clearly defined. Generally, assessors are understanding on
this issue in small laboratories and will recognize genuine attempts to achieve
the necessary separation within local limitations.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Deputies</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be provision for deputies
for all key posts, especially those of Quality Manager and Laboratory Manager,
so that their functions can still be discharged in their absence.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A common scenario is for Laboratory
Manager and Quality Manager to deputize for each other where the Quality
Manager has appropriate technical expertise, but you can make whatever
arrangements are suitable for your situation. The point to concentrate on is
that you must create a structure such that the laboratory is never going to be
paralyzed because it is not clear who can give an authorization or perform a function
the absence of a principal.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 recognizes that in small
organizations it may not be practicable to have designated deputies for all
posts. This does not alter the fact, however, that if the laboratory does not
have suitable arrangements for decision making in the absence of key staff is a
danger of running into a situation where work may have to stop if a
non–conformance with the quality system is to be avoided.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Look at your quality manual and analyze
the responsibilities allocated, especially with authorizing activities.
Consider the implications of the person to whom the responsibility is allocated
being absent. Would this create a problem in operating? If the answer is yes,
then decide to cover the absence by showing where the responsibility is
reallocated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.7<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other
Posts</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Apart from the requirements to define
the Quality Manager and the technical management structure, ISO 17025 requires
no other post to be defined. You should, however, look at your situation and
describe how it is structured.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For each level you should have an
appropriate name, for example, Chief Chemist, Senior Microbiologist, Materials
Scientist, Technical Officer, Laboratory Assistant, or whatever titles your
organization is familiar with.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">You should define, for each level, the
reporting structure both going upwards and downwards, for example each chemist
reports to a Senior Chemist and Technical Officers report to a Materials
Scientist.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.8<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Qualifications
and Job Descriptions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For each of the levels which you have
described under section 2.7, you should decide upon and record in the quality
manual the qualifications and experience necessary to fill the post. There
should be similar specific descriptions for the technical management posts and
the post of Quality Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">From quality point of view these
descriptions represent a commitment to provide staff of defined capabilities at
appropriate levels in the organization and to take suitably qualified and
experienced staff to replace those leaving. You should be careful not make the
criteria too restrictive but do choose criteria which demonstrate a genuine
commitment to have properly trained and qualified staff. Do not fall into the
trap of listing the qualifications and experience of the present incumbents.
The chances of your finding a perfect clone to replace them are remote. Think
in terms of the minimum necessary qualifications and experience for the post
and allow for using someone with appropriate experience and perhaps minimal
qualifications.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The description of the post should
include a brief job outline describing the duties to be carried out and the
level of responsibility to be accepted, including responsibility for
supervision.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The minimum content of the job
descriptions should cover responsibilities for performing tests/calibrations;
planning of tests/calibrations and evaluation of results; method development
and modification, and validation of new methods; expertise and experience;
qualifications and training programmes; and managerial duties.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The list below provides a useful method
which effectively aligns staff, for technical operational purposes into several
levels. Any individual may, of course, operate at more than one level.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Those providing support and who
never take responsibility for any data.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Those who carry out routine work;
such staff do not evaluate the data for release but will normally be expected
to do any initial checks required precisely defined quality control criteria.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff who exercise professional
judgements and evaluate data – normally those who can take responsibility for
the release of data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff responsible for training
and evaluating the expertise of trainees.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff responsible for selecting
and validating methods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.9<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Influences,
Confidentiality, and Independence</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The organization and management of the
laboratory must be such that the scientific staff are completely free to
exercise their professional scientific judgement. There must be no commercial
or financial pressures which might influence the quality of the work. This does
not mean that you cannot insist on a reasonable work rate from your staff, but
it would not, for example, be acceptable to pay them based on the number of
samples analyzed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All staff must be instructed that they
are required to keep confidential anything which they may learn because of
their work and any information which they are given to help them to carry out
their duties. The quality manual should contain a statement to this effect.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some organizations require staff to sign
a Confidentiality Agreement. This is not essential but is generally
recommended.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be instructions to staff on
the course of action to be taken if they believe that an attempt has been made
to subvert their judgement. The general instruction should be that the staff
member must inform the management as soon as possible and the management should
arrange to have the work in question passed to another employee, wherever
possible. It is emphasized that this is not done as a reflection on the
integrity of the staff member concerned but is required in defense of the
laboratory’s reputation and to remove any possibility of a suggestion that the
approach might have been successful.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><span style="font-size: medium;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype", serif;">3.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b><b><span style="font-family: "Palatino Linotype", serif;">The
Quality System and its components</span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key
Questions <o:p></o:p></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><span style="color: #01ffff;">For any particular result from your
laboratory, can you produce documentary evidence to demonstrate:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The work was done by a properly
qualified person who had been trained in the relevant technical operations and
had access to all information necessary to the proper execution of the work?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The method used was technically
sound and appropriate to the sample and to the requirements of the client.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The equipment used was properly
maintained and calibrated at the time the data was generated?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All appropriate quality control
checks were carried out and the results of such controls fell within the specifications.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">With respect to your management and
organization:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Are there clearly assigned
responsibilities for management of quality?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Are procedures in place
specifically designed to ensure quality is maintained?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Are there procedures documented?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a mechanism for
approval of this documentation and for ensuring that all copies issued are kept
up to date?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you monitor the arrangement
for managing quality to ensure they are fully implemented and being followed by
all?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where quality problems occur do
you have a mechanism for taking corrective action which seeks to develop the
quality system so that a recurrence of the problem is unlikely?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a mechanism for
identifying potential quality problems and taking action to prevent them from
materializing?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a mechanism for
identifying opportunities to improve the effectiveness of your quality system?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Purpose
of a formal quality system</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A professional will always take
precautions to secure the integrity of the data generated by his or her
laboratory. These will typically include calibration of instruments, checks on
the calibration, testing of samples in duplicate and the testing of quality
control (QC) samples for which the expected results are known.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Most of these operations come under the
heading of quality control. That is, they are designed to check that nothing
has gone wrong. A formal quality system will certainly include quality control procedures,
but it is much more oriented towards quality assurance. By quality assurance we
mean procedures and management methods which are designed to minimize the
chances of anything going wrong in the first place. The emphasis is on error
prevention rather than on error detection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the laboratory, the quality system
must not only deliver quality data but must also provide for the maintenance of
records which enable the quality of any result to be demonstrated historically.
The laboratory which can produce such supporting evidence will, without doubt,
have far more credibility than a competitor who cannot.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Having said all this, we must not lose
sight of the fact that the purpose of the quality management system is to
maintain and, where necessary, improve quality. Any records and documentation
must help towards this end.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">What we seek to do by formalizing the
quality management system and its associated documentation and records is to
ensure that quality management is applied comprehensively, appropriately, and
consistently. We also seek to establish an audit trail such that if something
should go wrong, we can tract the error and make modifications to the systems
that will reduce the likelihood of a recurrence, i.e., implement corrective action
which addresses the root cause of the problem.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Elements
of the Quality System</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Management of quality should be simply
one facet of each aspect of managing the laboratory. However, quality
management is so vital that it is usual to identify a separate quality
management structure. This will define clearly how responsibility and authority
for dealing with problems of quality are allocated in the laboratory. This
management structure is obviously the key element of the quality system. This
is the mechanism for doing things.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.3.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Documentation</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Documentation is important but it is
critical to realize that it is not the quality system. Because of the major
obstacle that you see when you decide to adopt a formal quality system is the
production of the documentation, it is easy to fall into this trap.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The documentation is simply one of the
tools of the system and has two main roles:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It
is a mechanism for defining the quality system so that there is a consistent
and secure basis for monitoring the system; in short, unless the system is
clearly specified it is difficult to monitor whether it is being used.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l21 level1 lfo3; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It
is a means of communication within the laboratory so that all staff know their
responsibilities and the procedures to be followed.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The key piece of quality documentation
is the quality manual. This is the document which describes in detail the
policy on quality and the quality management structure and describes or refers
to the procedures which constitute the working quality system. The quality
manual is, typically, prepared and checked by laboratory management, usually
under the overall coordination of the Quality Manager. It should, however, be
formally authorized for issuing from as high a point in the management
hierarchy as possible; Chief Executive, Director General, Chairman are typical
points. This ensure that the manual has the strongest authority and shows, to
the accreditation body, a commitment on the part of the senior management to
the quality system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is critical that the Quality Manual
is seen to be a working document. It should be available to all staff and they
must be instructed to read it and to use it to guide them in all aspects of
their work. It will then be a vital force for the consistent and comprehensive
operation of the quality system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manual may be completely
comprehensive and self– contained or it may refer to subsidiary documents which
describe procedures. Whatever the case, the Quality Manual must be the primary
source for all aspects of the operation of the quality system and must either
contain all necessary information or must explain clearly where such
information is to be found. Guidance on the preparation of the quality manual
is given in Section 16.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Laboratories will normally require
documentation of technical procedures in addition to the Quality Manual. The
key part of the technical procedural documentation will be the documentation of
the test or calibration methods themselves. The level of detail for these
methods should be such as to enable a trained practitioner to carry out tests
and calibrations in a proper and consistent fashion.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The technical procedural documentation
should also contain, or refer, to, operating details for all of the
instrumentation used to carry out tests. These details can be provided either
as part of the description of appropriate methods or as separate descriptions
of operating procedures. Such descriptions may refer to instrument
manufacturer’s manual or other sources of information and, provided these
sources are available, the information need not be repeated in documentation
prepared in–house. It may, for example, be appropriate to have general
operating instructions for a spectrophotometer, which are cross–referenced by
methods which require measurements with the instrument.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is not essential for the laboratory
to write up all methods and operating procedures. Where standard methods are used,
then, provided these are adequately documented to enable the method to be
performed properly and consistently, the requirement for a method description
can be met by making available to staff a copy of the standard specification,
for example, a national or international standard. See section 7.7 for further
discussion of methods documentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Similarly, equipment operating
instructions may be made available entirely in the form of manufacture’s
manuals if these provide all of the information necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A combination of the two approaches is
often used, with in–house produced documentation being produced to refer to,
amplify and clarify standard specifications and manufacturers’ manuals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Whatever the approach, the available
documentation must either contain all necessary technical information for
carrying out the laboratory’s scope of tests and calibrations or must make
clear where the relevant information is to be found. The emphasis must be, as
already stated, such that all have a source of reference to enable them to work
properly and consistently.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Consistency is particularly important to
the accreditation body since it is accrediting the laboratory and not the
individual staff members. An important function of the quality management
system is that it should ensure this consistency, and a key feature is to start
with a clear written definition of what everybody should be doing as regard
both quality management and technical procedures.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.3.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
System Records</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The records kept should consist of:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l39 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
original observations, raw data, calculations and derived data in the form of
work sheets, notebooks, instrument output, etc.; these must be dated and should
all be traceable to the person who made the observation or measurement and to
the equipment used – see section 11.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l39 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
of installation, maintenance, calibration, and checks carried out on
instruments and other equipment; this should be in the form of an individual
equipment log for each major item of equipment, or composite logs for smaller items,
such as balances, thermometers, glassware. See section 8.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l39 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Copies
of all reports issued by the Laboratory. See Section 13.2</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l39 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
of staff qualifications, training, and review of training in the form of a
staff register. See section 5.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l39 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
of all audits and reviews of the quality system, including records of
corrective and preventive action taken. See section 4</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l39 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
of all customer complaints and response to non– conforming work, and details of
follow–up and any corrective action taken. See Section 4.10</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l39 level1 lfo4; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records
of suppliers and subcontractors. See section 14 and 15.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The key objective in keeping records
should be to ensure that the source of any error can be traced and that any
test or calibration can be repeated in a manner as close to the original as
possible.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Records must be kept in such a way that
they can easily be retrieved if necessary and they must be secure, held in
confidence and reasonably protected from destruction.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a documented policy on
the period of retention of records. ISO 17025 has no actual period specified
but the laboratory must commit to a policy. Accreditation bodies usually have
their own regulations, and these vary from body to body.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">However, a typical requirement relates
to the practice of most accreditation bodies of carrying out a full
reassessment of a laboratory every four years. The normal requirement then
becomes that all records for the past four–year period must be available. After
the reassessment, most records for the four previous years can be disposed of.
The only rider to this is that any records which are relevant to ongoing issues
need to be kept for at the duration of that issue.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">What this means in practice is that
records relating to individual items of equipment, for example, need to be kept
for however long the equipment is in use plus whatever period is necessary to
reach the next reassessment. Most laboratories retain records far longer than
will be required by most accreditation bodies.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Document
Control</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A key aspect of the operation of a
quality system is that staff should be fully informed of their responsibilities
and the way the various procedures, including the test and calibration
procedures themselves, are to be operated. The main vehicle for passing on this
information is the documentation described in Section 3.3.1 above. This
documentation needs to be “controlled.”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A scenario all too often seen is that
laboratories create an unnecessarily elaborate document control system which
neither does the job required very well nor meets the laboratory’s needs. There
are only three reasons why the document control system is needed. They are:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">To
ensure that management is aware of, and has approved, all documents used by
staff to guide them in their work.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">To
ensure that all documents specifying procedures have been checked by someone
with appropriate knowledge to ensure they are accurate, technically sound, and
unambiguous.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l8 level1 lfo5; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">To
ensure there is a record of the timing of all copies of document, so that if
documents need to be reviewed, withdrawn or amended all copies can be subjected
to the same procedure.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The system established to achieve this
needs to consider the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l12 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
people reviewing documents before they are issued should be those with the
relevant knowledge. This is not an issue of management hierarchy. For example,
if the issue is whether a document is a correct and clear description of a
bench procedure, the best person to review it might well be a technician who
routinely does the work.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l12 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documents
may need to be issued and amended quickly and this should be done by the most
appropriately qualified person. For example, the issue or amendment of a method
is simply a matter for the laboratory technical management, who should be free
to act. Passing such issue through the sort of committee structure sometimes
seen for operating document control achieves nothing except a slow response.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l12 level1 lfo6; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">If
document issues and revisions do have cross department implications and so need
some discussions, the procedure for reaching agreement needs to be streamlined
and made efficient and not excessively bureaucratic.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Remember that the purpose of the
document control system is to allow appropriate and accurate documents to be
issued, amended, and withdrawn. Far too often, systems are encountered which obstruct
the issuing of documents.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.4.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Scope
of the document control system</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The document control system must be
described in the Quality Manual. This system must cover all documents used in
the operation of the quality system. These include obvious items, such as the
quality manual, associated procedural documentation, technical methods documentation,
and work instructions. Less obvious items which must be included in the
document control system are masters of pro–formas used for record keeping,
textbooks, posters, notices, calibration tables, memoranda, drawings, and
plans. Indeed, any document which provides information or instructions for use
in technical or management procedures must be controlled. This includes items
posted on notice boards and memoranda, for example of instrument settings,
which may be pinned to the laboratory wall.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is no reason why you should not
still have that list of certified values for your DTA – Differential Thermal
Analysis standards on the wall, but it must now have a signature and date
showing it is approved by management and has been checked as correct.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Controlled documents material published
material and other externally produced information, such as instrument manuals.
In– house–produced material is frequently issued to individuals, whereas other
documents are typically made available by placing them in defined locations in
the laboratory. There is, however, no reason why in–house material cannot also
be made available by being issued by storage locations. The onus will be on the
laboratory to show assessors that documentation is controlled and available and
that staff know where to find it.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The term “document” should be
interpreted with the broadest meaning as covering information in all forms,
including computer files, software and other electronic or digital information.
It is an increasingly common practice for laboratories to make their
documentation available on a computer network. This can make control much
easier and updating a very simple exercise. Obviously, such files must be
read–only for users and only capable of being amended by authorized persons. They
should also be prevented from being printed without authorization and
recording, since this will generate unrecorded copies of the document, which
will be missed by the updating process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">On a related point, the Quality Manual
must include an instruction that controlled documents, other than masters of
pro–formas (see Section 3.4.4), must not be photocopied by staff. The
enforcement of this is essential to maintain the integrity of the system since
the document control system must know of every copy of a document in
circulation to ensure that all are reviewed and updated when necessary.
Proliferation of unofficial photocopies will undermine the control system
completely.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some organizations seek to protect
themselves from photocopying of controlled documents by using paper of a
distinctive colour or by using paper with coloured logos or footer bands. A
rule can then be made that any copies of controlled documents which lack the
distinctive colour are not to be used by staff and must be destroyed if discovered.
It is also possible to obtain paper which prevents photocopying, but this is
expensive. These expedients do provide protection, but they are not without
cost and should not be necessary in a well-disciplined and audited
organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Allowance should be made in the quality
manual for the issuing of uncontrolled copies of controlled documents but only
outside the organization. This covers the need, which sometimes arises, to
provide customers with copies of, for example, quality manuals. There is
normally no necessity to provide regular updates to such issues and therefore
no need to commit to this in the quality manual. Documents issued in this way
should be clearly marked as uncontrolled, for example by a suitable stamp, and
the quality manual should include instructions that such uncontrolled copies
are not to be released within the laboratory and that, if they are encountered
by staff, they are not to be used as work instructions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.4.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Practicalities
of controlled documents and their organization</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The issuing and amendment of each
controlled document must be assigned as a responsibility to an individual or
specified group of individuals. No other person may make alterations to the
document or authorize its issue. As already emphasized, the assigned
individuals should be those with the relevant knowledge to evaluate the
document, irrespective of line of management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each hard copy of a controlled document
should carry a cover sheet which shows the following:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l33 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
clear indication that the document is a controlled document.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l33 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
version number and/or the date of the current version so that the most recent
version can be clearly distinguished.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l33 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An
individual identifier of the copy of the document, such as a copy number, the
date of issue of the copy and either the name of the person to whom the copy
was issued or the storage location for the copy.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l33 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
name, position, and signature of the person(s) on whose authority the document
is issued.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l33 level1 lfo7; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An
expiry of review date for the document.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any controlled document should also
provide information which enables a user to check that it is complete. Either
it should be paginated in the form “Page n of nn” or the number of pages should
be shown on the cover sheet. It is a good idea, when paginating a large, controlled
document such as a Quality Manual, to paginate it in separate sections rather
than continuously throughout. This avoids the necessity to replace the entire
document if a page must be added. Under these circumstances, each page should
show the section number, the page number and the total number of pages in the
section, and there should be a page of contents listing the sections.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The operation of the controlled document
system is normally one of the responsibilities of the Quality Manager, although
the actual day–to–day administration of document control and record keeping
may be delegated to administrative staff, for example in a library or document
control centre.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of each controlled document,
there must be a record which shows either the name of the holder or the storage
location of each numbered copy. When an amendment is authorized by the
appropriate person, the Quality Manager can then ensure that every copy of the
document is amended.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The simplest way to achieve this is to
collect all the copies of the document and to amend and reissue them. In larger
organization this many be practicable, and an alternative arrangement is to
issue the amended pages with instructions for the action to be taken by the
document holders. The pages should be accompanied by an amendment sheet which
describes exactly which pages are to be discarded and which are to be inserted.
This sheet should be placed in the copy of the documents so that there is a
full record of amendments.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 contains a specific
requirement that there be a master list or equivalent procedures so that staff
can check that they have the current version of a document. This provides an
additional safeguard but, provided the document control system is working,
there should be no obsolete versions around.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 contains a specific
requirement that there be a master list or equivalent procedure so that staff
can check that they have the current version of a document. This provides an
additional safeguard but, provided the document control system is working,
there should be no obsolete versions around.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 requires that, “where
applicable”, new or altered text be identified in amended or revised documents
or in attachments to the documents. The idea is that attention should be drawn
to the specifics of any changes so that staff can identify the key point and
determine easily whether changes in procedures are required or whatever the
changes are simply corrections of textual significance only, for example
removal of typographical errors. In the case of in–house documents, this is
easily achieved with moder word processing software which usually permits the
use of distinctive typefaces, and indeed colours to highlight amendments. In
the case of published material not generated in–house, it will normally be
necessary to provide an attachment to the document when issuing it, pointing
out the areas where changes have occurred. It is emphasized that the main point
should be to make it clear to staff when the amendment will require them to
change the way they carry out a procedure and when it is simply a textual
change.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Amendment to controlled documents can be
done by hand provided that the amendment is authorized by the person
responsible for the document. Normally, this will require their initials and a
date on the amendment. Hand amendment is only practicable in small
organizations where only one or two copies must be amended. ISO 17025 contains
a requirement that hand amended documents shall be formally reissued as soon as
practicable. In practice, it is preferable to avoid hand amendment since it
tends to lead to a sloppy approach to document control and almost always
results in variations creeping in between different copies of a document.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager should hold copies
of all versions of each controlled document so that, if necessary, the content
at any point in its history can be determined. These copies can be in the form
of computer files, provided they are properly protected by backing up.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.4.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Keeping
documents up to date</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a procedure to ensure
that controlled documents are reviewed from time to time. There is no set
interval for this in ISO 17025, but an annual review is typical. All copies of
a controlled document should show a review date so that users can immediately
see whether the document is overdue for review. The review requirements are met
if the person responsible for the document makes a record that the review has
been done and either authorizes amendment to the document or records that the
version as issued is confirmed as still relevant and requires no revision.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some published documents, for example
ISO or national standards describing technical methods, are subject to revision
by the issuing body. The laboratory will need to assure the assessors that
there is a mechanism for ensuring that such revisions are noted, and the
laboratory’s copies of the documents have been replaced with the update
versions. The simplest way is to have a list of all the documents in this
category and to check with a subscribing library or with the issuing body on a six-monthly
basis and, of course, to record the checks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This system of ensuring documents is
updated should encompass documents issued by the accreditation body.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It may sometimes be necessary to retain
copies of older versions of documents, for example standards describing
methods, for instance if clients wish the previous version to be used. The
requirement to update the documents does not preclude this but care must be taken
to ensure that the appropriate method is used for each client. Documents which
are obsolete for general use, but which are retained for specific purposes must
be suitably marked. The marking should either specify the scope of use of the
document or simply warn that it is not for general use and refer the reader to
an authority, for example the Quality Manager, who can provide information on
when it is to be used.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.4.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Some
issues specific to pro–formas</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For the first time in laboratory quality
management standards, ISO 17025 introduced the requirements to control
pro–formas used for record keeping. To be strictly correct, what is being
controlled is the format of the pro–forma.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The best way to meet this requirement is
to have a master set of pro– formas and to insist that any copies made for use
are always made from the masters and not from copies of the masters. The
masters may be hard copies or, more usually these days, a set of computer
files. There may be more than one set of masters but, as with all controlled
documents, each set must be numbered, and records kept of holders or location.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This system then ensures that, if a
pro–forma is amended, the amendment comes into use immediately. Staff must be
weaned away from the common habit of keeping a stock of forms in a drawer or,
which is worse, keeping a set of their own “masters” from which, they make
copies as needed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The masters, and hence any copies of
pro–formas, must show a version number/date of issue, the identity of the
person authorizing the issue, and a date when review of the pro–forma is due.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">4.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b></span><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: medium;">Monitoring
and Maintenance of the Quality System</span></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key
Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l19 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a mechanism for checking that your arrangement for quality management
are being operated on a day–to–day basis by all staff?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l19 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
this is found not be the case, do you have a mechanism for taking corrective
action to ensure that the situation is remedied and not likely to recur?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l19 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you use the information from any quality problem to enable you to identify
where the quality system can be improved, and do you act on this?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l19 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have mechanisms in place to scrutinize the quality system for areas where
improvements might be possible?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l19 level1 lfo8; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you review the performance of your quality system to determine whether it is
delivering the objectives which you have identified for it?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reasons
for Monitoring Quality System</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A laboratory must take active steps to
check that its quality system is being operated properly and that it is
achieving the required standard of quality. Quality control provides some
feedback on these issues, but this is not sufficient to meet the requirements
of ISO 17025. The system must be proactive and provide assurance of quality.
Moreover, the quality system itself must be under constant scrutiny.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 requires audit and review of
the system on a planned and regular basis, plus ongoing monitoring to detect
quality problems and even to anticipate and prevent problems. These are all
strategies designed to detect actual or potential nonconformances with the
quality management system before they impact on data quality. Where there are
no problems, the activities provide a record that the quality management system
has been scrutinized and found to be satisfactory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Audit and Review</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The organization of audits and reviews
is the responsibility of the Quality Manager, although he or she will normally
involve other staff in actually carrying out audits. The Quality Manager is
also responsible for checking that any corrective action agreed is adequate, is
carried out and is effective.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The frequency of audit and review of the
systems is not mandated in ISO 17025, but a note in the standard expects that
each aspect of the system will be audited at least annually and that reviews
will, likewise, be conducted at least annually.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Distinction
between Audit and Management Review</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An audit is concerned with checking that
the quality system in the quality manual and associated documentation has, in
fact, been implemented and being operated. To put it simply, the documentation
describes what is supposed to be done while the audits checks that it is being
done and, in the way, specified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Review is a management function where
the key members of the laboratory management examine the performance of the
quality system. The object is to decide whether the system is delivering that
is required. The requirements will be, as a minimum, compliance with ISO 17025
but may also include any local policy requirements thought relevant by
management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The review and audit process are
distinct but interact in the sense that the review will consider, amongst other
things, the audit reports. These will provide important information about where
the quality system is weak and in need of revision. In this respect, review
includes an element of preventive action – see Section 4.9.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Planning
the Audit and Review Programme</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is the responsibility of the
Quality Manager, but the plan should be considered and approved at the quality
system review meeting. See section 4.7 below.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An annual plan should be prepared, and
the proposed timing of audits should be marked on the plan and, when an audit
is complete, the actual date and name of the auditor should be added.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager should be given
complete authority to ensure that the plan is adhered to. The audits and
reviews should be treated as an important issue and not put off any reason
whatsoever. Experience shoes that, once a programme falls behind, it is
difficult to catch up.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Audits are a crucial issue in an ISO
17025 quality system since the whole philosophy is that the laboratory designs
and implements the quality management system and then carries out audits to
ensure that it is working properly. In the absence of audits, problems will
only be detected when they lead to quality failures. This is a quality control
approach aimed at error detection; an ISO 17025 compliant quality management
system is focused on error prevention through quality assurance, and it is only
through the audit that the laboratory can be sure that the system is working.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Nothing will make assessors more uneasy
than the impression that a laboratory does not take its audits seriously. A
pattern of audits being carried out late relative to the audit plant will send
the wrong message to assessors, and statements such as, “We had to put off
October’s audits until September because we had so much work in” are likely to
be interpreted by assessors as demonstrating low priority approach to the
quality system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.5.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Frequency
of Audit and Review</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">General practice is that an audit
programme should be organized on a rolling basis such that, in any one year,
each aspect of the quality system will be covered at least once. There should
also be at least two vertical audits in any one year. In a vertical audit the
auditor, rather than examining one aspect of the system, tracks a specific
sample or samples through the laboratory, from receipt to reporting of results,
and checks that the documented procedures have been followed and all records
kept.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is nothing in ISO 17025 which
precludes an annual, one–off, audit of the whole system, but this is not
regarded as good practice except perhaps in very small organizations where
external auditors must be used. The rolling system described, where audit is
seen as an ongoing part of management, is generally to be preferred.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Annual management reviews are generally
enforced by accreditation bodies, and it is unlikely that this will change.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">These timescales should be used on a
routine basis, but it is strongly recommended that the frequency be doubled
during the first year of operation of a new quality system, i.e., a six–month
rolling audit programme supported by a six–monthly review.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Audit Programme should be phased in during
the implementation of the various elements of the quality system and not
postponed until it is all in place. This provides a valuable check on the
elements of the quality system as they are established. A settling in period of
two to three months should be allowed for each part of the system and then that
part audited.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An efficient and responsive audit system
is a powerful too in establishing the quality system. Inevitably, people will
tend to forget to do things required by the quality system from time to time
but, if they learn that any omissions will be picked up quickly and corrections
asked for, they will rapidly acquire good habits and make fewer mistakes.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Auditing</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.6.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Choice
of Auditors</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The responsibility for audits lies with
the Quality Manager, who may carry out audits directly but will normally
delegate at least some of them to suitable individuals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Auditors should be familiar with the
principles of auditing and must be independent in the sense that no one may
audit an area of activity in which they are directly involved or for which they
have immediate supervisory responsibility. ISO 10011, parts 1 to 3, provides
useful guidance on auditor’s responsibilities and the organization of audit
programmes.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 does imply that, when
resources are not adequate, the independence requirement of auditors can be
relaxed, but experience suggests that accreditation bodies will take some
persuading on this issue.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In most laboratories it is usually
possible to do all auditing with internal staff, but there is no reason why
outside persons cannot be used. People from other parts of the organization to
which laboratory belongs are often suitable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A typical situation in a small
laboratory is that the Quality Manager carries out most audits, but some other
senior staff member is brough in to audit those areas where the Quality Manager
has personal involvement.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An auditor need not have a detailed
knowledge of the technical aspects of the work of the laboratory, but some
background is essential.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager is responsible for
ensuring that auditors are properly trained and should maintain training records
for them. These records can form part of the overall training records – see
Section 5.3. Training can be given in–house or by outside agencies, such as
consultants, can be used. A commonly applied strategy is for the Quality
Manager to undergo formal training in auditing and then for he or she to train
the internal auditors.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is sometimes appropriate, especially
with very small laboratories, to use external auditors to achieve independence.
These will normally need to be approved by the accreditation body, but there is
usually little problem with this since the accreditation body is happy to see
steps towards effective and independent auditing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.6.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Conducting
an Audit</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It needs to be clearly understood that a
quality audit is solely concerned with checking that what is actually happening
matches the documentation. Before starting an audit, therefore, it is essential
to agree on the documentation to be audited against. Normally, this will be a
part of the quality manual with, perhaps, some associated documentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Auditor should begin by looking at
the documentation and should plan exactly what is going to be examined during
the audit. The best approach is to prepare a checklist of questions to be
answered, documents to be examined and inspections to be made.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The checklist should be used as the
basis of the audit and should be covered comprehensively. Any questions which
the audit raises, and which require further investigations should be addressed
only after the checklist has been recovered. Too many diversions are likely to
result in the audit not being completed or being very protracted.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The way an audit is approached is
important. It should be seen by the laboratory as an opportunity to reveal any
potential problems before they lead to a quality failure and not as an
inquisition to be borne. The auditor should be seen as a valuable helper in
ensuring that quality is maintained.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This atmosphere is best achieved if the
auditor always remembers that his or her job is to audit the quality system and
not the people. Avoid any actions or statements which might the taken to
suggest that blame is being apportioned. If human error has occurred, the
approach must be to seek to modify the quality system to make this less likely
in the future.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Audit should be a forward–looking
process, oriented to ensuring that any problems do not recur. Past problems
should only be analyzed for the information which they provide and not as part
of a witch hunt to find a culprit.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Always remember that auditing is as much
about confirming the satisfactory operation of the system as it is about
finding problem areas. This means that Auditors must carefully record details
of the systems, records and items examined, especially if the report finds no
evidence of non–conformance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.6.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Audit
Reports</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The auditor must make a written report
on every audit. Other documents should be appended as necessary. It is
customary and helpful for a copy of the auditor’s checklist and notes to be
attached to the report.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some audit report formats make provision
for auditors to obtain a confirmatory signature from laboratory staff for their
observations. The idea is to confirm factual observations so that these do not
become a matter for later debate. The point needs to be made to the staff
confirming the observations that they are only agreeing to the facts and not
accepting that a non–conformance has occurred. It is only at the second stage
of the process of audit that the auditor will decide whether an observation is
to be reported as a non–conformance. The practice of having observations
confirmed is not an essential component of auditing and whether it is adopted
is a matter for the individual organization and will be very much determined by
the prevailing culture. It does, however, reduce the possibility of contentious
disputes since at least the facts of what was observed will not be at issue.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The audit report must detail exactly
what was examined during the audit and the findings of each examination.
Positive reports are required as well as negative since to stress the point
again, the audit is as much concerned with establishing that the system is
working properly as it is with finding problems.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The auditor must be able to provide
objective evidence for any conclusion reported. A general impression that all
is not well in an area is not an adequate basis for a report. When auditing, be
always objective and be able to prove your point without the need to debate the
question.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some systems incorporate the concept of
non–conformance, for example major, minor, etc. This is not recommended since
every non– conformance requires addressing with corrective action. A debate on
whether it is major, or minor is not relevant and merely time consuming.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The format of an auditor’s report on a
non–conformance must be objective and clear. In essence it should state “In
Section 123 of your quality manual there is a requirement to operate in the
following manner. Here is an example which I found where this is not being
done.”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">At the end of an audit, the auditor
should hold an exit meeting with interested parties. This will normally be the
laboratory management plus any other staff with supervisory responsibility in
the area audited. The auditor should give a verbal report on the findings, both
positive and negative.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">At this meeting there should be
agreement on any corrective action required and this should be recorded. The
record should show what action was agreed, the person responsible for carrying
it out and the timescale. This record can be part of the audit form, but many
organizations prefer to have a separate corrective action record since this can
serve generally. A need for corrective action can arise from causes other than
audit findings, for example client complaints or detection of non–conforming
work.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In determining the corrective action,
the objective should be to eliminate the root cause of the non–conformance and
to reduce the likelihood of a recurrence. To emphasize this, it is recommended
that audit report forms include a section where the root cause must be entered.
This aspect is strongly emphasized in ISO 17025 but, in practice, assessors
have always required such an approach. A quick fix for a problem with no
attempt to eliminate the fundamental weakness in the system will not meet with
approval.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager has overall
responsibility for checking that corrective action is taken and for making a
record of the completion. Follow–up arrangements should also be made to ensure
that the action has been effective. These arrangements should also be made by
the Quality Manager. In the case of many non–conformances, the follow up should
include a partial re–audit, at least, to be scheduled after an appropriate
lapse in time so that the working of the modified system can be tested.
Typically, one to two months should be considered. The plans for follow up and
the confirmation of its successful completion need to be recorded as part of
the corrective action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The completed audit reports should be
filed by the Quality Manager and will need to be available to assessors. It
should be appreciated that assessors’ prime interest in the audit reports will
be to check that corrective actions has been taken and followed through and not
to use them as a means of detecting the laboratory’s weakness.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.6.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Audit
Summaries</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is good practice for the Quality
Manager to summarize the results of audits. His summary should collate the
numbers and types of non–conformances, classified by the area of quality
system to which they pertain. The Summary should be presented at the management
review meeting.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The value of the summary is that it will
highlight the areas of the quality system which fail most frequently and so
help to focus the review. The summary can be particularly useful in
multi–department laboratories where it brings all the audit findings together
and can help to identify quality problems that are common to several
departments. Such problems are often most effectively addressed at the higher
management level rather than by individual departments.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.6.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Additional
audits</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In addition to the planned audit
programme there may be a need for audits in response to any occurrences which
indicate non–conformances with the quality system or with ISO 17025. These
would include internally reported quality problems, including detection of
non–conforming work, client complaints and actual quality failures which come
to light in any way whatsoever.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The audit should be organized to address
all the relevant parts of the quality system. The follow up is the same as for
planned audits, with appropriate corrective action being taken and its
completion and effectiveness verified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.7<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
System Management Review</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.7.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Composition
of the Review Committee</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">This should consist of, as minimum, the
Quality Manager and the Laboratory Manager with someone present who represents
the most senior level of management of the laboratory where decisions on
allocation of resources are made. This could be a representative from the board
of the company or the equivalent policy making body. The presence of such a
representative is key since there may resource implications in the findings of
the committee. Any other persons who might contribute should be present. These
would typically include senior professional staff and, perhaps, chief
technicians. In a small laboratory with only two or three staff, it is usually
most effective to involve everyone in the review.</span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><o:p> </o:p></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.7.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Administration</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager is responsible for
arranging the meeting and for compiling and distributing the agenda. He or she
should also ensure that all relevant documents are available. These should
include but not be limited to:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">All
audit reports and summaries, including reports by external assessors and any
but customers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Feedback
from customers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
proposed audit and review programme for the following year;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Details
of in–house quality control checks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reports
on quality failures and follow up action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reports
on customer complaints and follow up action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Preventive
action records;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l20 level1 lfo9; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">h.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Results
from participation in Proficiency Tests and other interlaboratory trials</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The meeting must be minuted and a list
of action points prepared. The Quality Manager is responsible for ensuring that
all the actions agreed at the review meeting are carried out, but the meeting
should agree on who will carry out each action and the timescale. This should
include the updating of any documentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.7.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Meeting
Agenda</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The purpose of the review meeting is to
look at the performance of the quality system over the past year and to decide
on any modification needed to secure improvements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The meeting should also consider any
modification needed to meet any changes to the quality management standard to
which the laboratory adheres and any changes needed to address new policy
objectives set by the organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The meeting should cover, at least, the
following topics:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
matters arising from the last review meeting and a report from the manager
confirming that all actions have been taken;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Report
on any surveillance or assessments by the accreditation body.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Discussion
of the results of all audits, both internal and external.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Review
of the quality manual and decisions on any changes required;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Performance
in Proficiency Tests and any similar interlaboratory exercises; plans for
future participation in such exercises;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">In–house
quality control checks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Complaints
from customers and follow up action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">h.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Results
from customer surveys and plans for future surveys.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">i.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
incidents and follow up action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">j.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Review
of staff training and plans for the following year.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">k.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Adequacy
of staff, equipment, and other resources to maintain quality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">l.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Plans
for staffing, equipment, premises, etc.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l15 level1 lfo10; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">m.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Agreement
on action points and date of next meeting</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.8<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Corrective
action</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Corrective action will be required
whenever a quality problem is identified. The audit is an obvious mechanism for
determining whether corrective action is necessary, but there is other
potential source of information, and all of these should be used. Obvious
sources are complaints from clients, information passed on from laboratory
staff about quality problems, detection of non–conforming work and direct
detection of quality failures because of quality control monitoring.
Interlaboratory Proficiency testing and feedback from external assessors and
auditors would also come into the category of useful sources from outside the
organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.8.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Because of the variety of sources giving
occasion for corrective action, it is useful to separate the record system for
reporting quality problems from the system for planning and recording
corrective action. This allows the same corrective action management and
recording system to serve for all sources of information on quality problems.
The audit, for example, is reported on a form dedicated to that purpose, and
this is cross referenced to the corrective action requests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The corrective action record system
should provide for the recording of the reason for the action and for a
detailed description of the proposed corrective action, with an explanation of
how it addresses the root cause of the problem. The responsibility for the
action should be assigned and a timescale agreed. There should a record of the
arrangements proposed to verify the effectiveness of the corrective action.
This will normally mean some type of audit, possibly of restricted scope,
covering only the immediate are of the quality system involved in the action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The Quality Manager should be required
to confirm when the action is complete and should also be responsible for
ensuring that the verification of effectiveness is carried out and recorded.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.9<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Preventive
action and improvement</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025, as compared to previous
laboratory accreditation standards, introduces a requirement for preventive
action. This is sometimes confused with corrective action but although there
are grey areas, the two concepts are essentially different.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l6 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Corrective
action is a response to a finding of a non–conformance or a quality failure,
i.e., what you do to put right something that has gown wrong and, where
possible, to make sure it does not go wrong again.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l6 level1 lfo11; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Preventive
action, on the other hand, is occasioned when circumstances are identified
where a quality failure or non–conformance is a possibility or where an
opportunity is identified to strengthen the quality system. In this respect,
preventive action is a total quality management concept and contains elements
of quality improvement.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There are two distinct streams of
preventive action:</span></span></b></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l17 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Actions
in response to a scrutiny of the quality system which identifies areas where
the system could be strengthened; such actions are, in a sense, voluntary for
management since the response can consider the degree of risk as opposed to the
benefit. This recognizes that any quality system can always be improved, but
there will be associated costs, some direct and some indirect, for example
reduced efficiency. If management decides not to take an opportunity for
preventive action on such a basis, justification needs to be recorded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l17 level1 lfo12; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Actions
in response to identified trends showing deterioration in performance; these
include trends in data but also encompass general performance indicators, for
example turnaround times. There is sometimes debate about whether this is
preventive or corrective action. this not fruitful. Action is needed; the
attached label is irrelevant. The point is that the laboratory is using a
mechanism to pick up incipient quality failures before they impact.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The essential requirement of ISO 17025,
as interpreted by most accreditation bodies, is that the laboratory must have
mechanisms for identifying when preventive action is opportune, in the sense of
opportunities for improving the quality system and responding to unsatisfactory
trends in performance. A typical set of approaches is as follows:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
brief of auditors should be extended to invite suggestions for where
improvements to quality management might be achieved within the area which they
are auditing. This activity, it should be stressed, is distinct from the audit
and should be reported separately.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
in general should be encouraged to offer suggestions for improvements in
quality management or where quality can be made more secure. This can be via an
anonymous suggestions system if it suits the culture of the organization to
proceed this way.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l31 level1 lfo13; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
should be regular formal scrutiny of trends in data, especially quality control
data, by the laboratory management. This should include interlaboratory
Proficiency Testing results. The objective should be to identify trends which
indicate potential failures, for example bias developing on Shewhart Chart.
This kind of scrutiny can be achieved by a regular meeting of senior laboratory
personnel, for example the Laboratory Manager and Senior Scientists. The
frequency of the meeting will depend on the volume of works, but monthly
meetings are commonly held.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.9.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a Preventive Action
record form. This should carry the suggestion for preventive action followed by
an evaluation by management and an explanation if the action is thought
inappropriate. It should be noted, however, that the 2005 version of ISO 17025
has a specific requirement for the laboratory to “continually improve” its
quality system, so arguments against the implementation of preventive action in
response to identified weaknesses are likely to be difficult to sustain in
future.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If action is to be taken, the proposed action
should be detailed, responsibility allocated, and a date for completion set.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager should receive a
copy of the form and should be responsible for following up to ensure that the
proposed action is completed and to record this.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.10<span style="font: 7pt "Times New Roman";"> </span></span></span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Client
complaints, quality incidents and other feedback</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.10.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Complaints</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">This is always a somewhat delicate
subject, but the reality is that no laboratory goes very long without some
queries or complaints from its clients. To comply with ISO 17025, the laboratory
is required to record all client complaints to investigate them systematically
and to record the result of the investigations and any corrective action taken.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is not intended to create a body of
evidence to be used against the laboratory but is rather a recognition of the
fact that such complaints provide a valuable source of feedback on the
operation of the quality system. After all, the main object of the quality system
is to ensure that clients are properly served.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.10.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Learning
from client complaints</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory should approach client
complaints as a source of information and they should be investigated in the
same manner as any other quality incident. If there is no substance in the
complaint, this can be recorded, with supporting evidence. If the complaint has
substance, then the laboratory should be able to provide a record which shows
the corrective action taken to rectify the problem and, most importantly, what
has been to reduce the likelihood of a recurrence. The investigation will often
require an audit of some part of the quality system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The investigation of such complaints is
the responsibility of the Quality Manager although, in most instances, active
participation of the laboratory management in investigating the complaint will
be required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.10.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Administration</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory quality documentation
should state clearly which staff members are allowed to respond to complaints.
This will normally be the Laboratory Manager and, perhaps, other senior staff
members.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The person responding must record the
complaint and the details of any response, apply a record of any corrective
action already taken or intended. The record must then be passed to the Quality
Manager, who should evaluate the action already taken.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager should decide
whether the action taken is adequate or whether further investigation and corrective
action is needed. The Quality Manger must decide whether an audit is required.
Overall, it is the responsibility of the Quality Manager to ensure that the
complaint has been properly dealt with, that corrective action has addressed to
root cause and that any lessons learnt have been incorporated into the quality
system. He or she is also responsible for ensuring that the record of any
corrective action is made – see Section 4.8. The Quality Manager should also
follow–up to establish that the action has been effective.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.10.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other
client feedback</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Proactive soliciting of client feedback
is now required by ISO 17025 since the 2005 edition. Both positive and negative
feedback are required. At the time of writing, it is not clear what mechanisms
assessors will expect to see for acquiring such feedback, but the kind of thing
generally expected is annual client surveys or feedback forms sent out with
test results. In practice, such surveys will cover aspects of the laboratory’s
client services that lie outside the technical area, since experience suggests
that it is more than likely that client feedback will address issues other than
data quality, for example turnaround times and sample collection.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.11<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
incidents, control of non–conforming work</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any quality incident should be
investigated and used as a source of information on weak points in the quality
system. It is recommended that laboratories have a form for recording quality
incidents, i.e., situations where quality comes into question or breaks down.
These forms can be used to record complaints, internally detected quality
anomalies, detection of non–conforming work and other quality failures. The
Quality Manager can then process these forms and determine whether further
action, for example audit or corrective action, is required.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The form should provide for reporting the
incident and should identify how it came to light, for example complaint,
detection of non– conforming work, etc. There should then be a section for a
report on any action already taken. An incident will normally require
corrective action, so there should be a section to cross reference any
corrective action requests as described in Section 4.8. If no corrective action
is proposed, then the reason why it is considered unnecessary should be
recorded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The report should be passed to the
Quality Manager, who must review it to determine whether the response if
satisfactory. If necessary, the Quality Manager should raise a further request
for corrective action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.11.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Control
of non–conforming work</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Detection of non–conforming work is a
particular example of a quality problem which is given special emphasis in ISO
17025. Non–conforming work is any work which does not meet the laboratories’
stated standards, either with respect to mode of execution or outcome, for
example quality of data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There needs to be guidance in the
quality manual on how such problems are handled. The system needs to address
the following issues.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
non–conforming work is detected, the work must stop and management be informed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
must be an investigation and report on the quality incident.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Corrective
action must be taken and recorded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">When
corrective action has been affected, only then may the work be repeated or
resumed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l28 level1 lfo14; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
system must make clear who is responsible for determining that the problem has
been resolved and that work may be started again. This will typically be the
Laboratory Manager or Quality Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">As with all such systems in ISO 17025,
the emphasis in on learning from experience and strengthening the position for
the future.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><span style="font-size: medium;"><!--[if !supportLists]--><span style="color: #01ffff;"><span><b><span style="font-family: "Palatino Linotype", serif;">5.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b></span><b><span style="font-family: "Palatino Linotype", serif;"><span>Personnel</span></span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key
Questions</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a record of the
qualifications and experience of your staff, with objective evidence of their
qualifications, for example copies of certificates?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a clear record about
your proposed scope of accreditation of which members of staff are authorized
to conduct each test or calibration?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a documented
procedure for training staff in quality issues and technical procedures,
including tests?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a documented
procedures for conducting evaluation of the competence of staff after training
and before authorizing them for the procedure in which they are trained?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a system for
recording training, including objective evidence of competence?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a mechanism for
identifying which staff conducted each procedure, or test or calibration?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
Records</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is necessary for the laboratory to
have staff training and competence records. These should include the following
elements, at least.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l14 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
record of each staff member’s formal qualifications, previous experience and
date of recruitment; all qualifications should be verified by inspection of
certificates or equivalent evidence. This can be done by the personnel department
or the laboratory management, but the record should include declaration, signed
by an appropriate person, of the evidence seen. This could be a Personnel
Manager, the Laboratory Manager, or the Quality Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l14 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
list of the activities for which the staff member has been trained; this should
include not only tests and calibrations for customers but any in– house
calibrations and other activities, such as quality auditing and administrative
activities, for example receiving samples. Sections 5.2.1 to 5.2.3 and section
5.3 below deal in detail with the content and format of the training record.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l14 level1 lfo16; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
record of regular re–assessment of the staff member’s competence at each of the
listed activities. This is dealt with in detail in Section 5.4.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The training record should also provide
for the recording of any outside courses attended by the staff member and for
personal certifications or memberships of relevant professional bodies. Since
the last two are often renewable by annual subscription, there should also be
provision for recording checks on this renewal by the laboratory management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">One of the purpose of the training
records is to provide a source of reference by supervisors who wish to ensure
that the person whom they intend to allocate to a task is properly trained and
that their training is up to date. They also form an essential of the audit
trail since, as well shall see later, all raw data must be traceable to the
person who generated it. The training records complete the loop by enabling a
check to be made that the person doing the work was adequately trained and
checked as competent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="color: #01ffff; font-family: Palatino Linotype, serif;"><span style="font-size: 12pt;">All entries in training records should
be made and </span>initialed<span style="font-size: 12pt;"> by the Laboratory Manager or Quality Manager and, in the
case of authorizations to carry out tests or calibrations, should be
countersigned by the employee. By doing the employee acknowledges that he or
she appreciates the extent and limitations of their authorizations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It should be emphasized that, since the
training records need to be accessible to supervisory staff, internal quality
auditors and assessors, it is extremely unlikely that normal personnel records,
even if they include all the necessary training details, will be suitable for
use in this context. Normal personnel department records are likely to contain
sensitive personal information unsuitable for such wide scrutiny.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The training records must be available
in the laboratory. Assessors will not accept training records held in the
personnel office at Head Office!</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.2.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Initiation
of the Staff Records for New Employees</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory management will need to
initiate a staff record and institute a training programme for each new
employee. Obviously, the content will depend on the employee’s previous
experience and known level of competence. However, irrespective of whether the
new recruit is of the highest general competence, it will be necessary for him
or her to be trained in the laboratory’s methods and procedures.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is not to question an experienced
new employee’s basic competence, but is principally designed to ensure that the
employee is familiar with the quality system, the way tests and calibrations
are done and how results are recorded in this particular laboratory, the object
is to achieve a maximum of consistency between measurements made by different
staff members. The new employee must have his or her competence assessed
exactly as for a trainee and must be observed carrying out the procedures for
which he or she is to be registered to ensure that the documented procedure is
being followed – see Section 5.3 below.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of a highly experienced new
recruit, this assessment of competence may not need to be preceded by extensive
training, but there must be a formal familiarization with the laboratory’s
procedures and an opportunity to read the documentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.2.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Starting
the staff records for existing employees</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Most laboratories starting up staff
records will have existing employees with known areas of competence. There is
no need to create a retrospective record of training for such persons. The
management should prepare an initial list of authorizations for existing staff
and should note that they were regarded as competent at the start of the
record. There is no need for assessment of competence for existing employees;
they will be covered during the first re–assessment of competence – see Section
5.7.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.2.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Routine
Operation of the Staff Records</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The staff records will become a complete
record of the training, promotion, assessment and re–assessment of competence
for each employee.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each record needs to show the dates over
which the training was given, the identity of the trainer, the identity of the
person assessing competence and the date when authorization to carry out the
procedure unsupervised was given. The entries must be confirmed by the
Laboratory Manager or Quality Manager and must be signed by the employee.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The areas of competence listed in the
record may be defined in any way suitable to the laboratory’s operations, but
for test/calibration methods there should be a direct correspondence between
the accreditation scope and the training records. From the assessment body’s
perspective, there are no grey areas. Either an employee is trained and
competent to carry out a test/calibration in the scope or is not.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Remember that, especially for new
employees, the training must include familiarization with the quality system
and with basic laboratory arrangements, such as sample numbering, storage of
samples and the mechanisms for recording data and reporting within the
organization.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where it is possible, objective evidence
demonstrating the employee’s competence should be attached. This might be a set
of data obtained by the employee on standards or reference samples, or perhaps
data which has been cross checked by repetition of the test by a staff member
already trained for the procedure. The person assessing competence should sign
such data as acceptable and reference should be made to the source of
authentication, for example a calibration certificate for a reference material
or the data from repeat determinations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
training and assessment of competence</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Training of staff to carry out tests or
calibrations must be an organized and formal process. The management must give
the responsibility for carrying out the training to a specific person who is
already authorized for the relevant test and who will act as Training Officer.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Staff undergoing training must not carry
out work on client’s samples or items for calibration except under the direct
supervision of the Training Officer. The Training Officer must take direct
responsibility for the quality of the work and must countersign all worksheets
and results in recognition of this responsibility.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">When the Training Officer is satisfied
that the employee is properly trained, the Laboratory Manager should be
informed. The Laboratory Manager must now arrange to carry out a competence
test on the employee, under direct observation by the Laboratory Manager.
Ideally, the test or calibration should be on items for which the results are
already established, for example references or items previously tested or
calibrated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">To accept the employee as competent to
be authorized for the test, the Laboratory Manager must be satisfied that the
documented procedure is being followed, that results and all other relevant
observations are being properly recorded and that the result being obtained are
correct as judged by the known values and normal quality control checks
operated by the laboratory. The general criterion for the acceptability of a
staff member’s competence should be that they can confidently expected to
follow the documented procedure and consistently produce data which falls
within the laboratory’s known performance band.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Laboratory Manager may delegate the
competence assessment to another member of staff, but this should be an
explicit process and the Laboratory Manager must confirm the delegee’s
assessment of the data generated by the trainee. Ideally, assessment of
competence should not be conducted by the Training Officer appointed for the training
being assessed. However, where Specialist areas of expertise are concerned,
this may be unavoidable as the Training Officer may be the only person with
adequate knowledge to conduct the assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In some quality systems the competence
checks are assigned to the Quality Manager as a responsibility. This is
perfectly permissible under the standard and has much to recommend it, but only
if the Quality Manager has the appropriate technical expertise.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In addition to authorizations to carry
out tests/calibrations, it may be necessary to have training and competence
tests on instruments or routing operations. This will depend to some extent on
the experience of the staff concerned and should be at the discretion of the
management. For example, in the case of junior staff with little or no
experience, it is entirely possible that they will require training in the use
of basic equipment such as volumetric glassware, balances and thermometers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The onus is on the laboratory to show
that its staff are properly trained, and the management should approach all
questions of authorization and competence testing with this in mind.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Once the management is satisfied that
the trainee is competent, an appropriate entry must be made in the staff
records; this should be signed by the Laboratory Manager or Quality Manager
and, in the case of tests and calibrations, the employee. The entry must be
supported by a brief report stating that the employee was observed carrying out
the test and giving a list of the operations performed, for example weighing
samples, colorimetric measurement, titration, etc. Copies of worksheets or
notebook entries completed by the trainee and copies of any instrumental output
should be attached. These should be dates and signed by the person conducting
the competence assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.3.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Multi–level
Authorization</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It is becoming increasingly common for
accreditation bodies to expect to see competence assessment being dealt with in
a multi–tier system with equivalent multi–level authorization. In such systems
the initial assessment of competence lead to an authorization to work
unsupervised, but the work is then subjected to further checks and, usually,
countersignature by a supervisor. Subsequently, a second competence assessment
is conducted and, if this is satisfactory, the authorization is extended to a
second level and the checks and countersignature dispensed with.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Re–assessment
of training and competence</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Competence of staff must be regularly
reviewed and, normally, re–assessed. The general practice is that the
authorization of a member of staff to carry out a particular test or
calibration should be reviewed at least annually. The key reason for the
re–assessment is to maintain consistency between data from different workers,
so, in disciplines where interpretation by staff is an important input, for
example textile testing and some are of microbiology and histology, assessors
may require more frequent re–assessment. Intervals of less than three months
between formal re–assessments are unlikely to be required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A useful strategy is to maintain a
record which summarizes, for each employee, how often they perform a test and
whether the data was acceptable or not under the laboratory’s normal quality
control requirements. This record has the dual purpose of monitoring competence
on a regular basis and checking that the staff member continues to have regular
practice in the procedure – see later in this section for further discussion on
this point. However, such a record must always be supplemented by a more formal
re–assessment as described in the next paragraph. This record can easily be
filled in when data is checked before release since the worksheets or other
form of recording data must identify the person executing the test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The formal re–assessment should take the
same form as the competence test described in Section 5.3 above. That is, the
employee should be observed carrying out the test to check that the documented
procedure is being followed, and results should be scrutinized and ideally
checked by a second person. Alternatively, reference samples can be used. A
common strategy for re–assessment is to have the employee carry out one of the
determinations which for part of the laboratory’s interlaboratory Proficiency
Test or measurement audit programme.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The re–assessment of each employee’s
authorization should be planned at the beginning of each year by the
management. The re–assessment should be supported by documentary evidence in the
same form as described for the competence assessment in Section 5.3 above, i.e.,
a report by the person observing and copies of results and instrument output.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If the review is unsatisfactory, the
management must withdraw the authorization pending retraining of the employee
and performance of a satisfactory competence test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A laboratory management should always be
aware that an employee, although formally trained for a test, might not perform
it for a period due to balance of work. Under these circumstances, and
depending on the complexity of the operation, it might appropriate to take the
view that the employee’s authorization should be withdrawn pending a refresher
course of training and re–assessment of competence. It is impossible to set
hard and fast rules for determining when competence should be regarded as
having lapsed; the complexity of the procedure is clearly an important factor.
As a rule of thumb, however, any test not performed over the past year would be
a reasonable candidate for refresher training.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Training
Policy and review of training needs</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 contains an explicit
requirements that the laboratory have policy and procedures for identifying
training needs and providing training of personnel. This requirement is,
essentially, focused on identifying the needs of the laboratory rather than on
the professional development of individual staff. The annual review of the
quality system (see Section 4.7) would prove one suitable forum for identifying
training needs. Such needs generally arise at one to two levels. Firstly, there
is the question of whether existing staff need to be trained to increase their
versatility within the current skill base to enhance the laboratory’s
flexibility and ability to cope with the workload for each test or calibration.
Secondly, there is a necessity to consider training needs for any planned
expansion of the laboratory’s capabilities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A suitable policy is to review the
overall picture as part of the annual quality review, but this should be
supplemented by specific reviews at regular intervals by the Laboratory Manager
and the Quality Manager. In addition to this routine review, whenever there are
staff changes, whether due to resignations or new recruitment, a review of the
implications of these changes and any resulting training requirements should be
made by the management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The other occasion when the management
should review training requirements is when the laboratory is introducing new
method or instrumentation. Such changes will, almost inevitably have
implications for training or for, possibly, recruitment of new staff with
appropriate skills not currently available in the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">These reviews must be recorded. The
record should show the reason for the review, identification of the
participants, the date and a summary of the conclusions reached, including any
proposed action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Obviously, training needs may become
apparent ad hoc, for example the laboratory may have an unexpectedly high
demand for a particular test and will need to train extra staff to meet the
need. The training requirements review is not intended to replace such normal
management response but rather to introduce a pro–active aspect into dealing
with training requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Action
when employees leave.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">When an employee leaves, the appropriate
entry must be made in the staff record. The records for the ex–employee must be
retained since they constitute a part of the laboratory quality record and may
need to be referred to if data is called into question. See section 3.3.2 for
details of appropriate retention periods for records.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.7<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other
entries in the staff records</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The information discussed so far
constitutes the minimum requirements of staff records. The management should
feel free to insert any other information on members of staff which is relevant
to their competence. This can include copies of reports on their progress in
the organization and records of promotion or experience gained on projects.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Such entries may be of any format but
should be signed and dated by the Laboratory Manager or Quality Manager and
inserted in chronological order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In some areas, for example,
non–destructive testing, staff need to hold personal certifications which may
be subject to re–assessment or renewal by subscription. Where this is the case,
the training record must include details which show that the certification is
current, and the laboratory must have a mechanism to check that the renewals or
re–assessments are carried out as required and are recorded.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><span style="font-size: medium;"><!--[if !supportLists]--><span style="color: #01ffff;"><span><b><span style="font-family: "Palatino Linotype", serif;">6.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b></span><b><span style="font-family: "Palatino Linotype", serif;"><span>Accommodation
and Environmental conditions</span></span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key
Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Have you considered whether there
are any environmental factors in your laboratory which might impact on the
validity of test or calibrations?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Are you conducting any tests or
calibrations where the published procedure which you claim to follow includes a
requirement for the work to be done under specific environmental conditions,
for example temperature or humidity?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have any activities which
need to be separated to avoid, for example, cross contamination?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have procedures in place
which will create an objective, auditable record that environmental conditions
which might affect tests or calibrations are controlled and monitored?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have clear instructions to
staff on actions to be taken when conditions move out of specifications?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Some
specific considerations</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.2.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Chemical
Testing</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of chemical analysis, the
cross contamination between samples and possible environmental contamination of
samples are likely to be overriding considerations. Another concern is that
chemical testing requires standards often comprised of pure samples or
concentrated solutions of materials which are being tested for at trace levels.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is common to monitor the temperature
of chemistry laboratories, although this is rarely necessary. It can be argued
that volumetric measurements are affected by temperature but, in practices, the
variations in modern borosilicate volumetric glassware over a temperature range
in which staff will be comfortable is not significant relative to other sources
of uncertainty of measurement.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The only reason for monitoring the
temperature in your laboratory is if data will be affected if a specific range
of temperature is not observed. You must then ensure that work stops if the
temperature is out of specification. The widely observed practice of monitoring
and recording the temperature in the chemistry laboratory every day as an
exercise and with no justifiable need for operations to be carried out in a
specific temperature range and hence no need for a response to the monitoring
results is a pointless exercise.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The following general rules should be
observed for good practice in general chemical testing work:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l43 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Provide
segregated areas with their own glassware for the storage of standards and the
preparation of concentrated solutions. Operate rules to ensure that only very diluted
solutions of standards necessary for calibration of equipment are ever
introduced into areas where samples are being handled and processed. Take
precautions to avoid spillage of standards, for example by carrying them inside
double containers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l43 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
samples containing high levels and low levels of the same targets are being
handled, for example pesticide formulations and samples for residues analysis,
carry out the sample preparation work and, where possible, the instrumental
analysis in well separated rooms with their own glassware.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l43 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
possible, provide segregated washing up facilities for glassware with
segregated uses. If this is not possible, the ensure a management regime such
that glassware is not interchanged, for example use clearly labelled baskets to
deliver it to and collect it from the washroom.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l43 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Enforce
good housekeeping and tidiness by general management pressure; have a
designated time each week for cleaning and tidying the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l43 level1 lfo18; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Have
a system for reporting and recording all spillages. Where foreseeable, have a
documented procedure for dealing with specific types of spillages.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.2.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Microbiology</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of activities such as
microbiology, the assessors will look very closely to see that the laboratory
is designed so that it is easily kept clean and any spillages can be contained
and thoroughly cleaned up. Impervious bench tops with good seals against walls
and floor and around fittings such as sinks will be expected. Floors need to be
continuous sealed surfaces. In practice, microbiology laboratories will need to
be air–conditioned with split type units and all windows sealed to prevent
opening. Entry to the laboratory should always be double doored with vestibule
and changing/washing area.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An issue often raised in microbiology is
that of whether reference culture of organisms should be held for control
purposes, bearing in mind the danger of contamination of the laboratory by
organisms which are the subject of tests on samples.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is no doubt that positive controls
are essential, so laboratories must work with them. The following precautions
are needed, however:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Segregate
storage of reference cultures in their own dedicated refrigerators and
freezers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Have
a segregated are for handling the references, ideally with a laminar flow
cabinet.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l35 level1 lfo19; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use
dedicated laboratory coats and overshoes/shoes for work in the segregated area.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The following will be expected in an
accredited microbiology laboratory:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l42 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Clear
segregation of samples, references, and media storage.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l42 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Dedicated
laboratory coats and footwear with a changing area where staff can wash.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l42 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
planned cleaning regime for the laboratory, covering benches, floors, windows,
light fittings, ventilation grills, air conditioner, water baths and
autoclaves. The frequency and actual scope of these activities is a matter of
debate between different experts, but accreditation bodies will normally have
technical guidance documents specifying their particular expectations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l42 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documented
procedures for dealing with spillages and records of spillages and action
taken.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l42 level1 lfo20; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: Palatino Linotype, serif;"><span style="font-size: 12pt;">Monitoring
of temperature and humidity: limits need not to be stringent but humidity above
50% and temperatures above 25</span></span><sup style="font-family: "Palatino Linotype", serif; font-size: 12pt;">o</sup><span style="font-family: Palatino Linotype, serif;"><span style="font-size: 12pt;">C can lead to problems of </span>mold<span style="font-size: 12pt;"> growth.</span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.2.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Materials
and product testing laboratories</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Into this category fall activities such
as textile testing, leather testing, paper testing and some mechanical and
electrical testing. Often the test procedures in these areas require that
samples be pre–conditioned and then tested under specified atmospheric
conditions. If these conditions are not met, then the test procedure is not
being followed and cannot be accredited.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Laboratories working in these fields
will need to have specialized equipment to control temperature and possibly
humidity. Moreover, the conditions will need to be independently monitored and
recorded to provide a record that any given test was, in fact, performed under
the correct conditions. The best way to do this is to have a continuous
recorder, such as thermohydrograph, so that a chart or computer record is
generated which can be archived. Such equipment must, of course, be calibrated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is not unusual to find laboratories
with temperature and humidity control where the control equipment is only
operated during working hours. Often such laboratories have a separate
atmospheric control cabinet, which is run continuously and where samples are
pre–conditioned.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This mode of operation is possible in an
accredited laboratory but is not entirely satisfactory. Moreover, careful
records are required as follows:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l5 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
atmospheric parameters must be recorded continuously so that the time when they
were in specification is clearly established.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l5 level1 lfo21; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
start and end time of each test must be recorded so that it is possible to
audit this against the atmospheric condition record.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.2.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Calibration
Laboratories</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Environmental conditions in calibration
laboratories are absolutely a key to ensuring that work can be conducted to
acceptable and known levels of measurement uncertainty. Most calibrations are
affected by temperature and many by humidity. Moreover, calibrations often take
considerable time to perform, so stability of environmental conditions is vital
to control uncertainty of measurement with reasonable limits.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Typically, the temperature of a
calibration laboratory must be stable to within at least one degree centigrade
and relative humidity to within three units. This requires high specification
air conditioning equipment and control systems and careful design of the
laboratory. Normal air conditioning systems in buildings are never adequate for
calibration laboratories, and dedicated systems with appropriate capabilities
need to be installed locally.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All doors to the controlled area need to
be double and, ideally, calibration laboratories should have no windows,
especially in tropical climates. Admitting sunlight places an additional load
on air conditioning and more seriously, may cause hot spots.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Temperatures and humidity must be
monitored continuously by equipment which generates a chart or computer record
so that audit is possible. It is also necessary, in calibration laboratories,
to maintain the atmospheric conditions continuously. The compromise of running
air conditioning only during working hours discussed above, section 6.2.3, for
testing laboratories is not acceptable in calibration laboratories. This is
because much calibration equipment and, especially, references need to be
equilibrated with the laboratory atmosphere so that they are in a stable and
reproducible condition. Since many items used, for example reference masses,
gauge blocks and standard resistors, are quite massive, such equilibration can
require periods of several days of continuous maintenance of the conditions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">In addition to the atmospheric
conditions, other considerations will be relevant to some calibrations. For
example, mass calibrations require a vibration free environment, and procedures
involving electronic measuring and reference equipment may be susceptible to electromagnetic
effects which must be eliminated.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Access
to laboratories and security</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A laboratory will need to have a policy
on access to laboratories by persons other than those normally working there.
This includes members of staff, perhaps working in other sections, management
and outside personnel, including customers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 has little to say explicitly
on visitors to laboratories except that in clause 4.7 (service to the
customer), laboratories are encouraged to allow clients access to monitor the
laboratory’s performance in relation to their work, provided confidentiality of
work for other clients is not compromised.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The key factors to consider when
allowing access to laboratories are confidentiality and any factors which might
affect the validity of data, for example contamination. There should be a
policy which ensures that:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l34 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It
is clear who may authorize access to the laboratory by persons other than
staff. This will normally be a senior person in the laboratory, such as the
Laboratory Manager. The person giving the authorization should be clearly
assigned the responsibility of ensuring confidentiality is preserved.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l34 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It
is clear which staff from departments of the organization other than the
laboratory and ancillary staff such as cleaners have access. Such access is
normally permitted where necessary for efficient working but should otherwise
be restricted.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l34 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
there are areas needing to be protected from unauthorized access, for example
areas where there are hazards for untrained persons or contamination risks,
such areas have active controls and that digital locks with restricted access
to codes are widely used.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l34 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
contamination is a possible issue, for example in microbiology laboratories,
any visitors to the laboratory are bound by the same rules about wearing
laboratory overalls and footwear as are workers in the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l34 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any
clients or other outside visitors are always accompanied when in the
laboratory. Some relaxation of this is normally operated with service engineers
who may be working in the laboratory for long periods and where continuous
supervision is impracticable. The best practice is to ensure that the engineer
is advised of the areas of the laboratory where he or she is permitted access.
The engineer should also have a clearly assigned person on the laboratory staff
to liaise with or who can be approached if the Engineer needs access to other
areas.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l34 level1 lfo22; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It
is common to have a signing in system for visitors to laboratories. Often local
safety regulations require this. This practice is encouraged since it
formalizes access although, of itself, it provides no barrier.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Overall, security of the laboratory is
necessary not only to protect confidentiality but also to ensure the integrity
of samples and data. There should be a clear barrier between public areas of
the organization and the laboratory and, ideally, a physical barrier such as a
door with a digital lock with, possibly, a doorbell for non–laboratory staff
wishing to enter.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Out of working hours, laboratories
should be locked or covered by active security. Samples should be separately
secured, ideally in locked storage, and data should, at least, be tidied away
into drawers or cupboards. In the case of laboratories where integrity of
samples may be called into question, for example forensic laboratories, this is
particularly important and a formal chain of custody for samples may be needed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Health
and Safety</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Comfort of staff and compliance with
health and safety legislation is not an explicit concern of ISO 17025, although
some national accreditation standards include compliance with local laws on
health and safety as a condition of accreditation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">On the other hand, assessors will
certainly not be impressed with a dangerous looking laboratory nor one where
working condition are poor. The rules of most accreditation bodies, moreover,
allow assessors to refuse to enter areas which they consider dangerous.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">7.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b></span><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: medium;">Test
and Calibration Methods, Method Validation and Quality Control</span></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key
Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a set of methods specified
as acceptable for use in your laboratory?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Are they documented to the extent
necessary to ensure they are applied properly and consistently?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Does your laboratory use standard
methods which are published and widely accepted?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">If not, do you have evidence to
show that the methods you are using are fit for the purpose of claimed and
acceptable to your clients?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Have determined the accuracy,
precision and, where relevant, the limit of detection of the methods which you
use, including standard published methods?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you run routine quality
control samples and evaluate the results before releasing data?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you monitor trends in quality
control results to anticipate possible problems?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Have you tested your methods and
laboratory by use of certified reference methods and/or interlaboratory
comparison?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Choice
of Methods</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 requires that the laboratory
use appropriate methods which meet the needs of the client and, where possible,
methods published as national, regional or international standards by reputable
technical organizations or in relevant scientific text or journals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where it is necessary to employ
non–standard methods, these must be agreed with the client and must be fully
validate and documented. Laboratories can develop their own methods, but these
will have to be fully validated to show that they are appropriate and fit for
purpose.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In practice, methods used by
laboratories fall into one of three categories:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Standard
methods which are published as standard specifications, for example ISO
standards, ASTM (American Society for Testing and Materials) and national standards
or are published in the scientific literature; where laboratories claim these
as part of their scope they must be followed precisely without variation from
the published specification. The laboratory will not have to carry out full method
validation but will have to have data to show that it can achieve the level of
performance which the standard specification claims for the method or, failing
that, a level of performance appropriate for the purpose for which the
measurement is being made.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documented
in–house methods which are the laboratory’s own methods; these must be subject
to a high level of validation. The accreditation body will need to see the
validation data, and assessors will have to be presented with data to satisfy
them that the method is technically sound, suitable for the purpose claimed and
acceptable to clients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l18 level1 lfo24; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documented
in–house methods based on standard specifications; this category makes up a
major part of many laboratories’ scopes since it avoids the commitment of being
pinned to the fine print of the standard specification whilst maintaining the
credibility provided by the standard specification. Placing an in–house method
in this category will generally reduce the amount of validation which a
laboratory has to do. The degree to which this is true, however, will depend on
the extent of the departure from the standard specification. Care needs to be
taken, when reporting data from such methods, to recognize the variation from
the standard specification. It is also necessary to ensure that clients are
aware of the variation and accept the resulting data as still being suitable
for their purposes.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An issue which often arises is where a
standard specification has been revised but the laboratory, or its clients,
wishes to continue to use the old version. The general rule is that clients of
the laboratory who request a test to a particular standard specification are
entitled to assume that the laboratory will use the current version and, if it
is using an older version, then they must be informed and advised of the
differences. Whether to proceed then becomes the client’s decision. On the
other hand, if the client specifies an older version, then the laboratory must
respect the client’s wishes, subject to the requirements to draw the client’s
attention to any limitations introduced by this choice.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any report must, of course, specify
exactly which method was used and note any deviations from the standard
procedure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The accreditation body will often be
reluctant to allow an older version of a standard method to be quoted on a
scope but there is nothing in the current version of ISO 17025 which precludes
this absolutely.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An out–of–date standard should be
included amongst the laboratory’s documentation only with care, and the
document should be clearly marked with details of when it is appropriate to use
it, for example for work for a particular client. The laboratory will have to
demonstrate to the assessors that there is no danger of the method being used
in error as the current version.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In cases where a client requests a
particular method, ISO 17025 place an explicit onus on laboratories to inform
the client when they consider the method to be inappropriate or out–of–date. Of
course, the client may still insist on the method despite the laboratory’s
reservations. In such circumstances, the laboratory may proceed but should
advise the client, in writing, of the limitations on the applicability of the
data which will result from the choice of method and should reflect its views
in any report issued.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory Quality Manual should
have a statement that the laboratory conforms to the policy of using standard
methods wherever possible and should quote a list of examples of sources
regarded by the laboratory as appropriate to its type of work. There should
also be a general policy statement on the laboratory’s perception of its own
area of expertise.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Review
of Requests, Tenders, and Contracts</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The requirements for recorded contract
review is ISO 17025 formalizes the process of interaction with the client on
the selection of a method. The onus is on the laboratory to ensure that, as far
as it possible to ascertain, the client receives a service which meets their
needs. Moreover, the laboratory must be satisfied, before accepting the work,
that it has the capability and resources to conduct it. In practice, any
responsible laboratory will go through this process anyway, but ISO 17025
requires it to be formalized and recorded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The sequence of event in contract review
should be something like this:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l38 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
request is received from the client.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l38 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory determines whether the request is clear in that it either identifies
specifically the test or calibration procedure required or make clear the
client’s objective in requesting the work.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l38 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
laboratory identifies whether the requested work is routine, in the sense that
it has a validated, documented, and appropriate procedure. If the work is
identified as routine, then all that is necessary is for the laboratory to
ensure that it can meet the client’s requirements on turnaround. There might,
though, be an issue here if the work requested involves an abnormally large
number of samples, for example.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l38 level1 lfo25; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">If
the work is not identified as routine, then it will be necessary for the
laboratory to determine whether it can accept it. This will require an
assessment of whether the necessary equipment and expertise is available. A
method will also have to be identified and arrangement made to validate it.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of work not obviously
routine or where instructions are not clear, however, and always on the initial
interaction with a new client, a full review will need to be conducted and
recorded. This complete process of contract review will normally involve
interaction with the client, culminating in the laboratory communicating its
intentions to the client and seeking their approval. All of this must be recorded,
including notes of telephone conversations, and correspondence attached. The
laboratory should have a simple standard pro–forma for recording the steps in
the contract review.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The pro–forma should identify who
conducted the review, the client details and contact information, and details
of the work requested, either explicitly or be reference to an attachment such
as purchase order. A part of the pro– forma should require and record an
assessment of whether the work is routine, in the sense that it can use one of
the laboratory’s standard methods. If work is identified as routine, then the
record can stop there, but the pro– forma should provide for further review and
records. These should include identification of the capabilities needed to
carry out the work: expertise, equipment, method selection and validation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Finally, there should be provision for
recording the client’s approval of the laboratory’s proposed approach to the
work. There are no absolute requirements to seek such approval in writing, but
the pro–forma should identify who gave approval on behalf of the client and the
means, for example in writing, by telephone, etc.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manual should document the
procedure for contract review and assign responsibility. The key aspect should
be to specify who may conduct the initial assessment of whether work is routine
or not. It will then normally be necessary to identify who has the responsibility
for determining whether a request for non–routine work will be accepted and to
assign authority to evaluate and commit the necessary resources.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Typically, the laboratory’s normal
process for receiving requests or samples from clients will from the front end
of the process, and relatively junior staff can operate this system and even
contact clients for clarification of unclear requests. However, the decision on
acceptance of non-routine or high-volume work will usually have to be referred
to management.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The standard does not require full
contract review process to be conducted every time an individual piece of work
is received. It recognizes that repeat work from established clients need only
to be subject to contract review at the initial setting up of the programme or,
subsequently, if there are any significant changes. For such repeat work, the
requirement to record contract review is satisfied by recording the receipt of
the work, the date and the identity of the person conducting the work.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is a common situation for
laboratories to receive routine samples from regular clients with little or no
information included on the work required. The laboratory knows the clients,
knows what they normally want, and the client assumes this. This can lead to
questions from accreditation bodies about how the laboratory communicates the clients’
usual requirements to staff receiving and processing samples and, especially,
how any changes in the clients’ requirements are communicated. The best way to
cover this is for a laboratory to have a set of documents in the sample
reception office which show the current requirements for each regular client.
These can then be referred to by staff. Such documents will form part of the
controlled document system and are updated as necessary when client requirement
change.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It may be necessary to revisit the
contract review during the work if any significant amendments are required,
perhaps because of changes requested by the client or, more commonly, because
of problems with test or calibration items themselves. The laboratory is under
an obligation to inform the client of any deviations from the contract and to obtain
approval. This must be recorded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A final note on sub–contracting,
contract review is required even if the laboratory subcontracts work. In this
instance, the review will involve the selection of an appropriate subcontractor
and agreement with the client to the subcontract. See Section 15 for further
discussion of sub–contracting.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Method
validation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.4.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">What
is Method Validation?</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Method validation can be seen as two
stage process, with the stages roughly equating to the somewhat outmoded
concepts of establishing precision and accuracy. In the first instance, the
laboratory needs to establish the extent to which it can reproduce measurements
and hence show that it can deliver consistent data within known limits. This is
only the first phase, however, since a laboratory which can reproduce
measurements well might still have a bias in its data. It could, so to speak,
be consistently wrong. To address this issue, the laboratory will have to look
outside and test itself against agreed reference points.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In calibration, the equivalent to method
validation is the establishment of the “best measurement capability.” This is a
measure of the smallest measurement uncertainty which the laboratory can
achieve for the specific calibration under ideal circumstances. Clearly the
reproducibility of the measurement is a key factor in limiting the best
measurement capability, but there must also be a test to establish whether
there is any bias which will also impose limitations. The “ideal circumstances”
referred to above pertain to a situation where the only source of uncertainty
is that arising from the calibration procedure and references, and where there
is no contribution from the item being calibrated. Clearly this represents a
practically unachievable ideal but is a useful concept in that it sets a lower
limit on the uncertainty of the calibration. Any real calibration must have an
uncertainty of greater than the best measurement capability.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.4.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Extent
of Method Validation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The key to determining how much
validation is needed for a method is to be found in the “fit for purpose”
requirements. The onus is on the laboratory to show that the method as applied
by it is suitable for the purpose claimed or demanded by clients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If the laboratory has devised the method
itself, then adequate validation might well be a very complex and involved
process requiring a demonstration of the scope of applicability of the method
in terms of samples and numerical range, selectivity, robustness in use,
accuracy, precision, bias, linearity, detection limit and any other relevant
characteristics.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If the method is a standard published
method, however, most of these factors will already have been investigated and
specified as part of the method documentation. However, whatever the origin of
the method, some validation will be required to establish that the performance
of the method in that laboratory is satisfactory. Even if typical accuracy and
precision data is published with the method, and the method is followed
precisely as written down in the literature, a laboratory cannot automatically
assume that it will reproduce these figures. There is no guarantee that the
laboratory’s skills or the performance of its instruments are of the same
standard as those used to generate the standard validation data. The laboratory
must always test its own capability directly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Assuming the method is being applied to
the same types of samples and in the same measurement range as specified in the
published method, then, as a minimum, the laboratory must determine what its
precision and accuracy are for the method and, if relevant, any limit of
detection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.4.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Relationship
between method validation and quality control</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Method validation is typically an
exercise undertaken when a laboratory device or adopts a method. Having
established the performance characteristics of the method, it is necessary to
put measures in place to ensure that the demonstrated performance is maintained
in routine use and to detect deviations from the ideal performance. These
measures are generally encompassed by the term quality control.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Quality control is a discipline–specific
activity but, in general terms, the ideal approach to it is to have samples or
calibration items available for which the expected result is known. These are
passed through the test or calibration process along with normal items for test
or calibration and the data generated from the controls is compared with the
expected values. Approaches to quality control and the evaluation of quality
control data are discussed further in Section 7.5.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Assuring
the Quality of Test and Calibration results</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use
of Certified Reference Materials</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An important way for methods to be
calibrated by laboratories is the use of certified reference materials (CRM). A
CRM is a sample for which the test results are firmly established and agreed,
ideally on an international basis. They are sold by some national standards
bureau and similar organizations and usually verified by highly respected
reference laboratories or by interlaboratory calibration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Acceptable procedures for certification
of reference materials are detailed in ISO Guide 35:1989, <i>Guide to General
Statistical Principles for the Certification of Reference Materials</i>. This
source also contains much information that can be equally applied in the
production of in–house reference materials. The effective use of certified
references and the evaluation of data generated by their use is covered by ISO
Guide 33, <i>Guide to the use of certified reference materials</i>.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A laboratory which wishes to calibrate
its methods can periodically check it performance by testing the CRM and so
establish traceability. Laboratories which can achieve correct results with the
CRM should, in theory, agree on any other test for the same parameters in the
same matrix.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">To be effective, a CRM must be typical
of the samples which the laboratories are testing on a routine basis. A method
of effluents will, ideally, require a CRM which is a typical effluent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Needless, to say, CRMs must be stable
and highly homogenous as well of established composition or properties. This is
readily achieved in some areas, such as in the chemical analysis of alloys, the
measurement of physical properties such as mass, dimensions, etc., and with
some geological samples, but things are not so simple in other areas of
testing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Materials testing, for example, often
represents a particular difficulty since samples are usually destroyed in
testing. The best that can be achieved here, therefore, is to have many samples
from the same source, for example cut from the same plate of metal or drawn
from the same concrete mix, and to test a statistically significant number to
arrive at an agreed figure for the whole batch.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Microbiology provides a different sort
of problem since sample stability is virtually impossible. However, in
microbiology there are, at least, certified reference cultures which provide a
definition of a particular organisms so that laboratories can verify that their
test systems are adequately selective. Some moves are in progress which it is
hoped will lead to the ability to prepare quantitative microbiological
references. These are generally based on the impregnation of cultures onto
plastic supports of controlled porosity.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where certified reference materials are
not available there are several alternative strategies, but the main approach
is participation in Interlaboratory Proficiency Exercises – see Section 7.5.5.
Such schemes, at least, give a laboratory a measure of its data relative to
other similar laboratories and, if organized properly, provide a very effective
alternative to the use of certified references. Accreditation bodies will
generally expect participation in appropriate schemes but, where certified
references are available, these will be expected to be sued as well.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Many basic test methods, especially in
analytical chemistry, are intrinsically traceable. There is no need to have a
certified reference for most titrations, for example. Here, traceability is
provided via the calibrations of the balance and volumetric apparatus. The purist
may argue that certification of the purity of the reagent which are weighed or
measured is necessary but, provided the origin of the compounds is known and
they are of known specification, it would be a harsh interpretation of the
standard to insist upon this.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Use
of Spikes</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Spikes are widely used for method
validation and calibration in chemistry and microbiology. They provide a
reasonable alternative to certified references, if the spiking material is
adequately authenticated, ideally by certification of its purity. On the face
of it, a spike has the advantage that the laboratory can spike into a matrix
which is typical of its normal sample stream. The counter argument is to
question whether a material spiked into the sample artificially is present in
the same distribution and speciation as the actual target. The strength of this
argument depends on the matrix. A metal ion spiked into a water sample might
well be regarded as a valid approach, but a pesticide spiked into a food sample
may be questioned on the grounds that the pesticide in real samples was,
perhaps, systematically absorbed by the crop used to make the food and so may
be bound into the cell structure. However, in complex matrices the spike may be
the only alternative, however imperfect it may be suspected to be.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A spike is generated by taking a real
sample and adding a known amount of the target in question. Ideally, the base
sample for the spike should have little or none of the target before spiking.
If this is not possible, the spike level should be large compared to the
natural level present. Of course, the natural level must be known in this
instance. The spike must be thoroughly mixed and distributed homogenously
throughout the matrix.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The spike does not provide true traceability,
but it can be reasonably assumed that laboratories which are able to
demonstrate good recoveries of spikes have good accuracy and hence will tend to
agree.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The use of spike is especially important
where laboratories are carrying out tests in complex matrices which may affect
the results. Examples are water analysis where matrix effects are common and
microbiology where components of the sample may well affect the viability of
organisms. The spike, at the very least, demonstrate that the laboratory would
detect the material or organism being sought if it were present.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">References
in Calibration</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The process of calibration involves the
direct comparison of the item to be calibrated against a reference. It is,
therefore, the reference itself which provides the guarantee of accuracy, and
so it is critical that the reference itself is maintained and checked
regularly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This will often only be possible by
sending the reference for calibration. However, in many instances, the
calibration laboratory can work with a hierarchy of standards whereby a
reference standard is maintained and used only for occasional checks on working
standards. In calibration of balances, for example, this is common. The
laboratory will have a reference set of masses and, possibly, several working
sets which are compared with the reference regularly. The reference is,
perhaps, calibrated externally annually.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
use of Quality Control samples</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Quality Control samples are used in the
same way as spikes and CRMs. They are merely samples for which the laboratory
has established values and acceptance limits. They are tested along with
unknown samples as a performance check. The laboratory may establish the values
of the analytical quality control samples by repeated testing, but they should,
ideally, be confirmed by at least two other laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If possible, quality control samples
should be calibrated against CRMs. In this instance they become transfer
standards, and the quality control sample provides traceability. This strategy
is frequently adopted when expensive CRMs are needed since the laboratory can
use the quality control sample routinely and check it only occasionally against
the expensive CRM.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO Guide 35 is a useful source of
information on procedures for validating in–house quality control samples and
confirming their homogeneity. Although, strictly speaking, the Guide is
intended to refer to the production of CRMs, similar principles apply to the
production of in–house reference materials for use as quality control samples.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">As with the spikes, quality control
samples which are not calibrated against CRMs do not provide traceability in
themselves but demonstrate consistency of performance on the part of the
laboratory. Such consistency, when combined with satisfactory results from
interlaboratory exercises showing that the laboratory normally agrees with its
peers, comes a very close second to establishing true traceability and is, in
many situations, the only possible option.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory will need to have a
policy on the use of quality control samples and for evaluating and responding
to quality control results. Guidance on this is given in Section 7.6.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
role of Interlaboratory Comparison</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Laboratories using spikes and other
forms of analytical quality control samples are effectively monitoring the
consistency of their own performance. They should have very good picture of
their internal reproducibility. If they perform well on spikes and on any CRMs,
they have also every reason to believe that their results are accurate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Nonetheless, it is in the interest of
any laboratory to test this assumption from time to time by exchanging samples
with other laboratories and comparing results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Such exercises are a very effective
extension to the internal quality control programme of laboratories. They also
provide an element of traceability when CRMs are not available since the more
laboratories agree on results and the wider the range of samples on which they
agree the more certain everyone can be of the accuracy of the collective
results. This is further reinforced if agreement spans several analytical
methods for the same determinant.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Interlaboratory studies may be informal,
in that a group of laboratories will exchange samples on an ad hoc basis or may
be formal exercises organized by a third party who circulates performance
indicators. Irrespective of how it is done, the crucial part of the exercise is
that the laboratory uses the data. This means reacting positively to any
results which indicate that it is not performing as well as the other
participants and carrying out remedial action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Participation in appropriate
Interlaboratory Proficiency Schemes will normally be required by accreditation
bodies, and some bodies operate their own schemes. Although interlaboratory
comparison is listed in ISO 17025 as only one of several quality maintenance
options, most accreditation bodies will insist on its use wherever possible. If
there are schemes available in a laboratory’s sphere of activity or
opportunities for ad hoc exchanges with other laboratories operating in the
field, the accreditation applicant will have to provide good reasons to the
accreditation body for not participating in these activities. The accreditation
body simply sees inter–comparisons as the most stringent test of a laboratory
and wants to see the laboratory subject itself to such a test.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The recently changed world security
situation has resulted in severe difficulties in shipping samples for
Proficiency Testing across national boundaries, especially by airfreight. This
has, unfortunately, coincided with an increase in the insistence, by
accreditation bodies and particularly by the regional laboratory accreditation
conferences, on Proficiency Testing as an activity for accredited laboratories.
As a result, it is becoming almost essential for any national accreditation
body to ensure that adequate Proficiency Testing is available within the
country before it can seek international recognition through MRAs and
conference membership.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Accreditation will not normally be
conditional upon any level of performance in interlaboratory comparison, but
what will be required is for the laboratory to have a documented procedure for
evaluating the results from its participation and for responding to any
problems revealed. There must also be records showing that the results were
evaluated and what action was taken to remedy problems.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The accreditation body will not withdraw
accreditation based on isolated instances of poor interlaboratory proficiency
performance. However, if a laboratory is consistently failing in Proficiency
Testing and not taking effective corrective action, accreditation will
certainly be jeopardized.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of calibration laboratories,
it is usual for accreditation bodies to organize interlaboratory comparisons.
These are normally referred to as measurement audits.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.5.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedure
for Evaluating Performance in Interlaboratory Comparisons.</span></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This activity must be formal, as noted
above. A suitable approach is for the senior laboratory staff to meet and to
evaluate performance. The evaluation should consider the laboratory’s known
uncertainty of measurement. Whenever the laboratory determines that the result
which it has returned differs from the expected result or from the mean
obtained by other participating laboratories, then an investigation to
establish the reason for the problem and the initiation of appropriate
corrective action is called for, together with measures to check that the
corrective action was effective. See Section 4.8 for discussion of corrective
action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The meeting should be minuted and the
agreed action and its expected outcome, recorded. Even if the meeting concludes
that the laboratory's performance was satisfactory, a record must be made.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The accreditation body will expect to
see a file of the reports on interlaboratory comparisons and, with each report,
a record of evaluation of the data (the meeting minutes) and a report on any
corrective action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other
methods for assuring confidence in results.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of many methods, neither
certified reference materials nor effective spikes are available. There may,
however be what are often referred to as consensus standards, recognized by all
parties concerned. These would include many industry standards, such as those
used in, for example petroleum source rock analysis or colour fastness
measurements. Such standards may not be traceable in a strict sense but are
used to ensure consistency of data within the industry sector and hence form a
basis for agreement when testing against product quality standards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is another approach to testing
that is also recognized as a means of providing confidence in results, a
well-established one in analytical chemistry: determinations by different
methods which lead to comparable answers, which are generally persuasive.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Repeated determinations are also used to
provide confidence in results. Such confidence may be misplaced since errors
may be repeated, especially systematic errors resulting from poor design of the
system or errors in making up reagents. Where repeat determinations can be
valuable is if samples are retained over a relatively long timescale and then
resubmitted, ideally blind to testing personnel, to check the consistency of
the data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Correlation of results from different
characteristics of an item is also mentioned as a quality assurance method in
ISO 17025. The extent to which this is relevant will depend not only on the
type of testing being carried out but also on whether the client has requested
a range of tests rather than isolated test. There are no explicit requirements
for the laboratory to do additional tests to provide data for such
correlations. Most laboratories will scrutinize data in this way where they
can, for example in water analysis to confirm pH, the hardness, alkalinity, conductivity,
and dissolved solids present consistent picture. This type of scrutiny should,
however, be systematized and there should be guidelines in the methods
documentation on the criteria to be used in the assessment so that it is made
consistently.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.5.7<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reference
Methods</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of some determinants,
different methods may give different results. This may arise because all the
available methods are imperfect or because the method effectively defines what
is measured.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">BOD is an example of the latter, and BOD<sub>5</sub>
at 20<sup>o</sup>C with measurement by Winkler titration is generally accepted
as the definitive method. Many foods proximate analyses also fall into the same
category. Measurements of “fat” or “fibre”, for example are clearly method–dependent since they do not measure precisely defined chemical species. If
“fat” is determined by weighing the material extracted with pentane, for
example, the definition we are adopting for “fat” is that material which is
extractable by pentane.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In these cases, the “correct” result is
defined in terms of a reference method which is tightly specified, and
traceability effectively means traceability to the reference method.
Laboratories using methods other than the reference method should calibrate
them against the reference method from time to time and would be under an
obligation to demonstrate that any method which they choose to adopt gives data
comparable to that from the reference method.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Even where targets are clearly defined,
it may be necessary to agree on a reference method. This will arise when there
are several methods which typically return different results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Ideally, the technical problems implied
by the inconsistency between methods should be resolved, the best method chosen,
and the rest discarded. Sometimes, however, it is not possible to come to a
definitive answer on which method is technically superior and, especially where
enforcement is the issue, one method is arbitrarily defined as giving the
correct result to solve the impasse. <span style="mso-spacerun: yes;"> </span></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Under these circumstances,
interlaboratory calibrations are essential since the method defines the refence
values and this is meaningless unless all participating laboratories can
produce results which agree when all use the reference methods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Application
of Quality Control and managing response to results</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Laboratories have traditionally approached
quality control by including items of known properties in each test or
calibration batch and evaluating the results against defined criteria to decide
whether the data for the batch should be rejected or accepted. This approach
has the virtue of simplicity and, provided the accept/reject criteria are set
properly it will defend the laboratory’s contention that released data
continues to meet defined performance characteristics.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">However, if laboratory only used its
quality control data in this fashion, it is failing to make full use of it. A
laboratory might have situation where all the quality control samples are
producing data which falls within the acceptance limits but always on one side,
for example they may be consistently high relative to the expected value. This
situation bears investigation since there should be a random scatter about the
expected value. This bias, therefore, gives an early warning of a problem with
the test or calibration system. What is useful is that the problem has been
detected before the data is compromised.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Increasingly, assessors expect
laboratories to make us of their quality control data in this fashion.
Paragraph 5.9.1 of ISO 17025 makes explicit reference to recording data in this
fashion. Paragraph 5.9.1 of ISO 17025 makes explicit reference to recording
data in such a way that trends can be detected, which strongly implies the use
of control charges. The next section introduces the use of control charges
which might be adopted by a laboratory which is new to the area of statistical
quality control.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.6.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Statistical
Quality Control and Preventive Action</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be an active coordination
of quality control with a regular review of performance, and records should be
kept of the results of reviews and any action taken in response. This should
provide a mechanism of anticipating problems with methods before they affect
quality and as such is an important contribution to preventive action. See
section 4.9 for further discussion of preventive action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The management should collect the
results from quality control samples for each method and plot the data on a
control chart. The most common control chart format is the Shewhart Chart where
the difference between the expected and found values for the quality control
samples is plotted against time.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Shewhart Chart (see next page) gives
a general visual indication when any systematic drift in the values returned by
quality control samples is setting in. A method which is being used under
control should show a random distribution of the actual values about the
expected result, and any trends developing which suggest a bias should be
investigated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It is usual to mark the control chart
with a warning limit at two standard deviations (2</span><span face=""Arial",sans-serif" style="font-size: 12pt;">δ</span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">) and an action
limit at three standard deviations (3</span><span face=""Arial",sans-serif" style="font-size: 12pt;">δ</span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">). The standard deviation is generally
derived from the performance data determined at method validation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory should, wherever
possible, have a documented policy for deciding when the chart indicates a
condition where the method should come under investigation, and this policy
should be expressed quantitatively so that it will be applied consistently. In
setting rules for a particular method, the following widely accepted practice
should be borne in mind.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Approximately
5% of results may be expected to fall outside the 2</span><span face=""Arial",sans-serif" style="font-size: 12pt;">δ</span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"> warning limits.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any
result outside the action limits requires investigation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Two
consecutive results outside the warning limits need an investigation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
consistent run of successive results on the same side of the expected value
should be investigated. It is widely accepted practice that a run of eight such
successive result triggers an investigation although many laboratories would
feel the need to respond rather earlier than this.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Consideration should be given to
updating the control limits at regular intervals. If the method is consistently
delivering data inside the current warning limits, then this may indicate that
the uncertainty being achieved in practice is improving relative to the data
generated at validation. Conversely, if the method is slipping out of control
too often, this suggests that the validation data is presenting an optimistic
picture.</span></span></p>
<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitgyJEv7FcbQLYLSM1TscQo-tzGTmQC1AfGB8OWWISJvfTzwOYNHuha9N_iRLeyY_7jw_19uvJd_9SWnkho7ooTAQwYZLf62e8EcoW1KBTu--GZOE2WWklM2yIuX-sm2MTw8ybZ6-769EArKZDG1rJid_yzFlkyRExodYcsrWiFEyJnzr7oLm0r61Z/s983/Shewhart.jpg" style="margin-left: 1em; margin-right: 1em;"><span style="color: #01ffff;"><img border="0" data-original-height="739" data-original-width="983" height="301" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitgyJEv7FcbQLYLSM1TscQo-tzGTmQC1AfGB8OWWISJvfTzwOYNHuha9N_iRLeyY_7jw_19uvJd_9SWnkho7ooTAQwYZLf62e8EcoW1KBTu--GZOE2WWklM2yIuX-sm2MTw8ybZ6-769EArKZDG1rJid_yzFlkyRExodYcsrWiFEyJnzr7oLm0r61Z/w400-h301/Shewhart.jpg" width="400" /></span></a></div>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A common rule of thumb is to review the
data every sixty points. If 1 – 6 (inclusive) points are found outside the 2</span><span face=""Arial",sans-serif" style="font-size: 12pt;">δ</span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"> limits, then
the indication is that the limits are satisfactory. If more points are found
outside, then the limits are optimistic and either they should be revised, or
the method investigated to bring it back to a level the performance required.
If no points are found outside, then 2</span><span face=""Arial",sans-serif" style="font-size: 12pt;">δ</span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"> new limits should be set reflecting the
enhanced performance. Some laboratories take the view in this last case that
they will not reduce the limits since this will result in increased rejection
of data. In these circumstances, the decision on whether to revise to tighter
control limits will be determined by whether the un–revised limits are
acceptable in the sense that they indicate that the method is fit for purpose.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.6.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Frequency
of Quality Control checks</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is no simple answer to how
frequently quality control items should be run. The trite answer is as often as
necessary.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A general rule of thumb is that they
should be included at a minimum rate of one quality control items in twenty but
ideally one in ten. Experience of a method in a particular laboratory may
indicate that more frequent checks are required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of methods which involve
batch treatment of items, at least one quality control should be present in
each batch.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some items can be tested or calibrated
in duplicate as a check on the reproducibility of the method. It is far more
useful, however, to expend the same effort in testing another quality control
standard since this not only checks consistency but also gives information on
overall error.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A method which can only be controlled by
a high frequency of quality control checks should be looked at very carefully
and seriously considered for replacement by a more stable method.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.7<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Documentation
of Method</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Irrespective of whether the method is
in–house or standard, the staff must have documentation to enable it to be
applied properly and consistently. In the case of standard methods, this may be
covered by providing staff with access to the standard specification. It will,
however, normally be necessary to supplement this with instructions on the use
of models of instrument and with information on local quality control regimes
and the quality control data to be collected.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Another common situation where
supplementary documentation is likely to be required is where a standard
specification requires choices of procedure, based, for example, on sample or
calibration item type. The laboratory must ensure that the option chose will be
selected consistently irrespective of the person doing the selecting. It may,
therefore, be necessary to provide guidance on how to make the choice in the
supplementary documentation since standard specification are frequently less
than explicit in this area.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In–house methods will need complete
documentation; section 7.8 contains a suggested format. This can also be used
as a checklist for determining whether published documentation is adequate. If
it does not cover all the points noted in Section 7.8, then any omissions will
need to be provided for in in–house–generated documentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where the method is an in–house method
based on a standard specification, there will need to be documentation
specifying the variations from the standard and cross–referring to the
specification.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All the documentation of methods must be
issued as controlled documents. This is typically done by compiling a methods
manual consisting of in–house methods documentation, any supplementary documentation
for standards methods and a list of standard methods used by the laboratory.
The methods manual should also contain information on where the standard
specification can be found in the laboratory. It will normally also need to
refer to the appropriate instrument manuals and instructions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Suggested
format for in–house methods documentation.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each page of the method must show the
method number, the date of first issue and the date of the current version.
Pages should be numbered in the format page…of…. The method number is of
critical importance since it provides an unambiguous identifier for the method.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A suitable arrangement for the page
header is:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Method No.: M/0001<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Page 1 of 10 <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Fist issued February 1066<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This issue: March 1993</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The following sections should be
included in the documentation except where the Quality Manager decides a
section is inappropriate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.1<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Title</span></i></b><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The title should be brief but must
include a reference to the property to be measured or the calibration objective.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.2<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Scope</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This should clearly identify the range
of items to which the test or calibration is applicable and any limitations on
the range of any parameters which are measured, for example, suitable for
measuring lead in wastewaters in the range …. to … ppm.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.3<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Principles
of the Method</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A brief description of the principles
behind the measurement or calibration must be given; for example a coloured
complex is formed between the metal ions and dithiozone. The concentration is
determined by comparison of the absorbance of the solution of 259 nm with the
absorbance produced by solutions of known concentration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.4<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Sample
requirements for test methods</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The type of sample to which the test can
be applied must be noted here. This section also contains instructions for any
special sampling techniques, sample handling and preservation, sample
preparation or pre–treatment required. Alternatively, it can refer to other
documents in which these procedures are described.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.5<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Materials</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any materials or consumables used by the
method must be specified together with any required standards of purity or
performance. Any quality checks on reagents must be described or the method for
carrying out the checks must be referred to. Avoid referring to specific
supplies or products in this section, unless the source is critical to
obtaining the correct quality of material, otherwise you run the risk of having
non–conformance merely because your usual supplier has no stocks, and you used
an alternative.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.6<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Equipment
and Calibration</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A brief description of the equipment
must be given, with instructions on whether calibration is required before each
use and how this calibration is to be carried out. Calibration instructions
need not to be explicitly included in the method, but a reference where they
can be found is then essential.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Routine calibration as described in the
equipment log need not to be covered here; only such calibration as is part of
the method need to be included. Instruction to check that calibration markings
and labels are up to date is a wise precaution, however.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Reference standards, including any
certified reference materials, required for calibration should be specified. It
is also appropriate there to specify any quality control standards used and to
indicate the basis of their calibration, for example by checks against
certified reference materials.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.7<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Setting
up and Checking</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Instructions for setting up the
equipment must be given here, followed by instructions for any checks required
to confirm that the equipment is operating properly prior to use. The criteria
for passing the tests must be given and instructions included on the
information to be recorded about the tests.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It should be clear from this section
what action is required when check criteria are not met. This need not to be a
detailed description of how to remedy problems but might refer to a manual or
merely instruct the user to refer the problem to, for example the Laboratory
Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.8<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Environmental
Factors</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any environmental variables which should
be considered or measured and recorded as part of the test or calibration must
be noted. This would be relevant, for example, in the case of most calibrations
and in materials testing where certain ambient temperature ranges may need to
be adhered to for the test or, possibly, the temperature of the test may need
to be recorded in the report.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.9<span style="font: 7pt "Times New Roman";"> </span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Interferences</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any interferences, for example spectral,
chemical, physical, etc. which might affect the results should be detailed with
any precautions to be taken to minimize such effects.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.10<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedure</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A detailed description of the procedure
must be given, including any quality control measurements required, for example
duplicate or reference measurements. The level of details is difficulty to
specify for any test or calibration, but the assessors will have to be
satisfied that the description defines the procedure adequately to enable to be
carried out in a consistent manner by different staff. You can, of course,
assume that the staff have been trained. There is no compulsion to attempt to
produce a description that could be followed by a raw recruit.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.11<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Recording Data</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section must give precise
instructions on the data to be recorded from test/calibration items and for
quality control. The format of any tables for results must be specified. Where
worksheets are used, an example should be included with specimen data filled
in.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.12<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Calculations</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Full details of any calculations to be
carried out must be included, with instruction on how calculations are to be
checked, for example by spreadsheet, there should still be a description of the
calculations required and a clear identification of which sheet is to be used,
for example file name.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.13<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Assessment</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section must precisely specify the
criteria to be used to judge when results meet the necessary quality standards.
This may include details of the correspondence required between duplicates or
the values required to be returned for quality control. The objective, again,
is to achieve consistency. There should be enough detail here to ensure that
any person using the guidelines will come to the same conclusions. This
normally means defined quantitative criteria or reference to rules for
interpreting statistical quality control data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Instructions on the response required to
a failure in quality control must be given. This may simply be a requirement to
rerun the test or calibration. Where this is not technically possible, it will
normally be necessary for the Laboratory Manager to decide and, in most
instances, to contact the client.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.14<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Performance
Characteristics (uncertainty)</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The known performance characteristics of
the method should be given. This will generally be determined when the method
was first validated but, where values are subject to review as part of the
quality system, it may be necessary to refer to another document, for example
records held by the Laboratory Manager on current performance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Either uncertainty of measurement must
be specified, or instructions provided on how this is to be calculated in any instance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.15<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reports</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The data to be included in the formal
report which will be sent to the client must be described. This section should
include details of the units to be used and any qualifiers to be added to
reports, for example uncertainty estimates. This section is not necessarily
relevant to the person carrying out the test but is necessary to have a complete
specification of the test for audit purposes.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.16<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Safety</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any safety precautions to be taken and
any hazards known to be associated with the method must be specified. An ISO
17025 assessment does not deal with safety, but the inclusion of safety
information in methods in generally regarded as good practice.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.17<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Site Use</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where methods are carried out on site,
any special precautions needed to ensure that data is valid must be noted. This
should include checks on instruments or references to confirm that they have
not suffered in transit. If site checks are not possible, then the equipment
should be checked before leaving the laboratory and immediately upon its
return.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.18<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">References</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Reference must be made to any standard
specifications or published methods of relevance. Any manuals, technical
documents or other relevant sources of information must be listed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l40 level4 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.8.1.19<span style="font: 7pt "Times New Roman";">
</span></span></span></i></b><!--[endif]--><span dir="LTR"></span><b><i><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Authorization</span></i></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 108pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The signatures, with dates, of the
Laboratory Manger and Quality Manager, with dates, accepting the method for
use, must appear. The Laboratory Manager is responsible for ensuring that the
method is technically sound and that all relevant validation has been carried
out and evaluated. The Quality Manager will normally carry out a check to
ensure that all of this has been done and will, in addition, check that the
level of documentation and tis content complies with the requirements of the
quality policy as expressed in the Quality Manual.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.9<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Authorization
to deviate from documented procedure</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is inevitable that occasions will
arise when the documented procedure cannot be followed exactly. This normally
happens when samples or calibration items are untypical and technical
adaptations must be made.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is not a problem provided that the
decision to deviate from the documented procedure is made by an appropriately
qualified person and that the details are recorded. If relevant to the
interpretation of the results, the deviation must also appear on the report. In
practice, all such deviations are likely to be relevant and so need to appear
on the report except in clear and exceptional circumstances.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory must document in the
Quality Manual who is authorized to approve deviations from standard
methodology. This should normally be at the level of professional staff or even
the Laboratory Manager. The objective should be to ensure that the decision is
not made by a junior staff member who may well not understand the full
technical or service implications. The person authorizing the deviation should
be made responsible for ensuring that the necessary records are made.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Considerations should also be given to
whether a deviation needs to be discussed with the client of the contract to
review requirement – see Section 7.3. This is will normally only be necessary
where the deviation affects the utility of the data, for example when it calls
into question whether the test method can still be regarded as complying with a
standard specification.</span></span></p><p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">8.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b></span><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: medium;">Equipment</span></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key
Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a system for
commissioning equipment and verifying its performance and calibration before it
is used for test or calibration work?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a plan for periodic
calibration and verification of the performance of all equipment which affects the
validity of measurements?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have records showing that
this plan is followed, and which enable the status of any equipment to be
verified at any point in its history of use?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Is equipment subject to regular
checks or calibrations labelled so that its status can be seen immediately by
users?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Equipment
Records</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 effectively requires a
complete history of each piece of equipment. This should start with details of
the checks and calibrations carried out before the equipment is placed in
service and continue with a detailed record of all calibration, repairs,
routine maintenance, and performance checks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In this context, “equipment” should be
understood to encompass any items which may affect the validity of measurements
or calibrations, including reference standards of measurement, such as standard
weights and reference thermometers.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The best way to keep these records is to
institute an equipment log for each item which is, ideally, kept in the
laboratory next to the appropriate equipment. In some cases, it may not be
practical to keep the log next to the equipment, but it should be close by and
readily accessible. Experience shows that maintenance actions are more likely
to be recorded if the log is at hand. If staff have look for it, they may out of
making the record and perhaps forget altogether. In addition to the logs for
each piece of equipment, the management should hold a master list of all the
equipment, the management should hold a master list of all the equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is not absolute requirement to
issue a number to each piece of equipment, but this is strongly recommended,
especially when several units of the same type are in use. Unique numbering of
equipment by the laboratory avoids confusion. Serial numbers issued by manufacturers
can be used, but these are often log and cumbersome and frequently not easily
accessible.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Commissioning
of new equipment</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All new equipment must be checked for
correct functioning before being placed in routine service. This should include
checks against the manufacturer’s specifications and checks to confirm that the
equipment gives satisfactory results when used to make the measurements for
which it is intended. Where equipment needs calibration, this must also be done
before it is put in service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In this context, note that the fact that
a piece of equipment is new does not mean it does not need calibration. Unless
it is supplied with a certificate showing traceable calibration, it must be
calibrated before it is used for the first time. Additionally, note that some
piece of equipment, for example balances, must be calibrated in situ, so even
if these are shipped with a factory calibration certificate, calibration after
installation and before use will be essential.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where the equipment replaces or
duplicates existing equipment, the checks should include a comparison of the
results from each unit to establish the variations which might result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The basic details of the equipment and a
report on the commissioning checks should be recorded as part of the equipment
log. Supporting evidence such as results and instrument output should be
attached. The Laboratory Manager should also approve the checks and sign to
accept the equipment into service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Equipment undergoing trials must either
be segregated or clearly labelled as not to be used so that there is no
possibility of its being inadvertently used for routine work until it is
formally accepted.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 paragraph 5.5.5 gives a list
of information which must be on record for each piece of equipment. This
information should appear as the initial page of the equipment log.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Service
and Calibration Schedule</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Before introducing any piece of
equipment into service, the management should decide upon a
service/maintenance, calibration, and performance checking schedule. This will
normally be a combination of service from the supplier and in–house checks and
calibrations. There is no need to have outside service or service contracts,
but there would be a general onus on the laboratory to satisfy any assessors
that the arrangements are adequate to ensure proper and reliable functioning of
the equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The proposed regime should be recorded
in the equipment log and approved by the Quality Manager or other identified
person as being technically acceptable and compatible with the quality policy.
Having a definition of the proposed service/calibration schedule easily
accessible in the log makes auditing easy since the proposed regime can be
quickly checked against the actual records, which are also in the log.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Servicing and preventive maintenance
should be recommended by the manufacturer who may also be able to carry out
calibration checks and adjustments. Section 9.5.2 below deals with strategies
for deciding on calibration intervals. Whichever strategy is used, the approach
should be conservative to pick up any calibration problems before they affect
data quality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In–house checks or equipment should be
scheduled to cover the gaps between any service visits and calibrations. Some
equipment is effectively checked each time it is used by means of reference
samples which are run as part of quality control. Maintenance and calibration
are then carried out on an as– needed basis when these checks show a
performance deterioration. This is perfectly legitimate strategy provided that
the results from the reference samples are recorded either in the equipment log
or along with the analytical data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Do not, however, lose sight of the fact
that such checks can conceal underlying deterioration in performance. For
example, a colorimeter may give perfectly acceptable results even if its
wavelength calibration has shifted provided it is calibrated with the standards
at each use. However, if you are no longer taking the reading at the absorbance
maximum, your detection limit will certainly be degraded, and precision will
also suffer in most instances. Gas Chromatography detectors can be coerced into
performing by turning up the amplification, but this does not alter the fact
that, as the detector becomes dirty, detection limit, signal to noise and
dynamic range performance will be degrading.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For this kind of reason, most equipment
will require some formal checks even if it is effectively checked with the
standards at each use.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Responsible
persons</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is a good idea, especially in larger
laboratories, for the management to appoint an individual to be responsible for
each piece or class of equipment and this person should have a deputy. The
responsible person will have a watching brief over the equipment and will be
responsible for ensuring that the necessary maintenance, calibrations, and
checks are carried out and recorded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Routine
operation of the equipment log</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Every action taken – supplier’s service,
in–house trouble shooting, routine checks, etc. – must be recorded in this
equipment record. Any supporting documentation, such as service reports,
calibration certificates and output from performance checks, should be attached
to the record. This document should become a complete history of the equipment
so that its state of calibration and performance at any point in time can be
demonstrated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.7<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other
components of the equipment log</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In addition to the records, the
equipment log can usefully contain, or be kept with, a copy of operating
procedures for the equipment, including the manufacturer’s manual. If it is not
practicable to keep this information as part of the equipment log, then the Log
should give the location of the operating instructions and manuals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In cases where equipment operation is
described adequately in the methods documentation, there is no need to repeat
this information in the equipment log.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.8<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Smaller
items of equipment</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All equipment which affects the validity
of measurements will have to be recorded, but for smaller items it is not
essential to have a full equipment log. Examples would be such things as
thermometers, volumetric glassware, timers and even balances. In these
instances, a composite log covering, for example, all the laboratory’s
thermometers, would be appropriate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.9<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Equipment
labelling and sealing.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each piece of equipment which is subject
to regular checks or calibration should carry a conspicuous label which shows
the date when it was last checked or calibrated and the date when next due.
This should be signed by the Laboratory Manager or the person responsible for
the calibration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The staff should be instructed, via the
quality manual that they must not use any equipment where the label shows that
it is overdue for a check or calibration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where there are limitations on the
calibration of equipment, for example, if it is not calibrated over its full
range, there should also be a label indicating the limitations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In some laboratories there may be
equipment which is only used for indication purposes and so is not rigorously
calibrated. Such equipment should carry a label showing that it is not
calibrated and hence not to be used for measurements where traceability is
required. Examples might be rough balances or timers used in undemanding
applications.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 is subject to some different
interpretations in labelling of uncalibrated equipment. Some schools of thought
regard it is as fatuous to label an item as uncalibrated. In practice, however,
the onus will be on the laboratory to satisfy assessors that there is no danger
of confusion leading to the sue of uncalibrated equipment when calibrated
equipment is required. The simplest way to achieve this is to label all
indicator equipment as such.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Equipment which is effectively
calibrated at each use should carry a label to this effect with a reference to
the calibration instructions, which might be within a method description. An
example would be a pH meter which might labelled “CALIBRATE AT EACH USE, Ref
Method CA/001.”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some equipment is difficult to label in
the conventional sense. Volumetric flasks and thermometers can be a particular
problem. There is still a requirement to mark with the calibration status, but
this could be by means of a color code or other marking. For example, all
calibrated thermometers could have a piece of distinctively coloured tape would
round their stems and the laboratory could have a notice saying, “CALIBRATED
THERMOMETERS ARE CODED BLUE – Expiry Date 31<sup>st</sup> May 2007.”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where equipment which is calibrated or
verified at regular intervals has adjustment screws which should only be
adjusted as part of the calibration procedure and are not needed in normal use,
these should be sealed in some way, for example by signed labels, to prevent
tampering, or at least prevent any tampering being unrecognized.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.10<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Equipment in use
before formal records are implemented.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In practice, most laboratories will have
an inventory of existing equipment before implementing equipment logs.
Reasonable effort should be made to retrieve information to set up the logs,
but assessors will recognize that not every piece of information will be
available. For example, a reasonable estimate of the date when the equipment
was received will be acceptable, and there is no need to for extensive research
to establish a precise date.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Commissioning test information will
similarly be typically absent, and the relevant part of the log should simply
be endorsed: “EQUIPMENT IN USE AT IMPLEMENTATION OF RECORDS,” or some similar
wording. Ongoing checks and calibration will establish the equipment’s integrity
from now on.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">If you do have any historical
information on the equipment, however, for example copies of service reports,
calibration history, commissioning reports, then include these in the equipment
log.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Traceability
of Measurement</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key
Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Have you identified all the
measuring equipment, which is involved, directly or indirectly in measurement
or calibration and which, if not properly calibrated, would affect the validity
of measurements?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Is this equipment calibrated in a
manner which provides traceability to the international measurement system?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have a management
procedure to ensure that the calibration is always maintained, i.e.,
recalibration is conducted as necessary and, where possible, equipment is
monitored so that any drift away from calibration will be detected?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l32 level1 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: Symbol; font-size: 12pt; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do you have records which could
be audited to confirm the calibration status of the equipment at any point in
the past?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Meaning
of Traceability</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Basically ISO 17025 requires that a
laboratory has in place a calibration system which ensures that, within known
limits of uncertainty of measurement, any tests or calibrations which it makes
are comparable with those of any other laboratory. The key element in achieving
this is to ensure that all equipment, in all laboratories, which has an impact
on the validity of calibrations or tests is calibrated in such a manger that
there is an unbroken chain of comparisons which lead from the equipment to a
recognized international standard of measurement. Wherever possible, this
international standard is required to be the corresponding SI unit of
measurement.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The ideal way in which the system works
in practice is that a country establishes a national metrology system where a
central metrology laboratory holds the national standards for all measurements.
This central laboratory establishes a link into the international measurement
system by, from time to time, checking its standards against those of other
countries and participating in interlaboratory measurement audit exercise. In
the latter case, the laboratories circulate references, for example a mass or a
thermometer, and all compare them with their own standards, so establishing a
basis of agreement, or otherwise, between the national calibration laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Laboratories and industry requiring
calibration can then go their own national metrology laboratory to have their
equipment calibrated in the knowledge that the calibration is internationally
traceable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Such national metrology systems do not
exist in all countries, and in these cases, it will be necessary for
laboratories seeking ISO 17025 compliance to establish traceability by having
calibrations performed by agencies outside the country which are able to
provide the necessary traceability. These could, for example, be a national
metrology laboratory in a nearby country.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some equipment can be sent to the
calibration laboratory for calibration and then shipped back to the laboratory,
but many systems are either too bulky for this approach or they need
calibration on site, for example balances, as calibration is invalidated by
their being moved. This inevitably means bringing calibration personnel and
references to the laboratory site.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This extra–national approach to
traceable calibration is both inconvenient and expensive so it is in the
interest of countries seeking to establish a network of ISO 17025 compliant
testing and calibration laboratories to seriously consider establishing a national
metrology system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Acceptability
of calibrations to accreditation bodies</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is obviously of crucial importance to
laboratories seeking ISO 17025 accreditation that they derive their calibration
in a manner which will be acceptable to the accreditation body. The mere
existence of a national metrology system claiming international traceability
will not necessarily guarantee such acceptance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For an accreditation body to be
satisfied with a calibration, they will need to know that the calibration
service complies with all the key requirements of ISO 17025. Ideally, the
calibration service, even if it is a national metrology laboratory, should be
accredited to ISO 17025 by an accreditation body acceptable to the body being
engaged to assess laboratories which depend on the calibrations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If the calibration service is not
accredited, then the accreditation body will normally need to investigate it to
satisfy itself that the calibrations are adequate, and that traceability is
intact.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Unfortunately, different national
laboratory accreditation bodies have widely divergent views on the calibrations
which they will accept, broadly speaking, it is more likely that calibrations
will be accepted if obtained directly from a national metrology laboratory than
if from a commercial calibration service drawing its calibration from the same
national metrology laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Around the world, some national
metrology services have established reputations, but even this does not
guarantee acceptance by any specific accreditation body unless there a formal
mutual recognition agreement. However, calibrations from the national services
in the Republic of Singapore, the Republic of Korea, the Republic of India, the
Kingdom of Thailand, most EU countries, Japan, Australia, New Zealand, the
Republic of South Africa, and NIST in the United States of America are
generally well regarded at the time of writing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The key issues on which the
accreditation body will need to be satisfied with in any calibration are as
follows:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
the references used are properly calibrated and provide international
traceability.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
the calibration procedure being used are scientifically sound, of known
performance characteristics, for example uncertainty of measurement, and
subject to proper quality control.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l16 level1 lfo30; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
staff carrying out the procedure are properly trained and competent in the
calibrations performed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is strongly recommended that any
laboratory intending to use a particular calibration service, even a national
metrology laboratory, enter a dialogue with the body chosen as a potential
accreditor for the laboratory along the following lines:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l41 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Determine
whether the calibration service has ISO 17025 accreditation and who its
accreditation body is. Ask the proposed accreditation body for your laboratory
whether they have mutual recognition for calibration with the accreditation
body of the calibration service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l41 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">If
the calibration service is not accredited, then ask the proposed accreditation
body for your laboratory whether they have any policy on the acceptance of
calibrations from the proposed calibration service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 54pt; mso-list: l41 level1 lfo31; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">If
the issue is still unresolved, ask the proposed accreditation body for your
laboratory what information they would require deciding on the acceptability,
or otherwise, of calibrations from your proposed calibrations service. What
they will normally ask for initially is examples of calibration certificates;
information on how the calibration service establishes its traceability; what arrangements
the calibrations service has for measurement audit or inter–comparisons with
other calibration bodies; and whether it has a pro–active and audible quality
system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Essentially, the rule is to establish,
at as early a stage as possible, that your proposed accreditation body will be
likely to accept the calibrations you are proposing to rely upon. There is no
point in spending time, money, and effort on setting up calibrations which are
simply rejected at assessment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Measurements
not traceable to SI Units</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.4.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Industry
and Consensus Standards</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There are many areas of testing, where
measurements are not strictly traceable to an SI unit. Many types of product
testing fall into this category and rely not on a fundamental unit but on a
recognized industry standard. For example, colour fastness in textiles is
measured relative to a specific standard blue cloth. There is no SI unit for
colour fastness. Similarly, measurements such as abrasions and pilling
resistance rely on comparison with standard samples or photographs of samples.
The basis of the comparison is universally accepted but it is not a fundamental
unit as such.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 allows for this in testing and
in calibration through paragraphs 5.6.2.2.2 and 5.6.2.1.2 respectively. Here
the idea of traceability to a certified reference material, a reference method
or a consensus standard is accepted where relevant.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A difficulty which sometimes arises in
this area is that some accreditation bodies persistently refuse to apply these
clues of the standard and insist that they will only offer accreditation for
calibrations and measurements which are traceable to SI units. Strictly
speaking, this is a practice discouraged by ISO 17025, which frowns upon
extension to the standards, but nonetheless it is a present problem for
laboratories seeking accreditation. If you have tests which fall into this
category, then it is advisable to determine the attitude of your possible
accreditation bodies before becoming committed to them as accreditor.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.4.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reference
Materials</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In addition to industry standards there
are increasing numbers of what are typically referred to as certified reference
materials which are used to establish accuracy in measurements or calibrations.
Some discussion of the use of certified references has already taken place in
Section 7.5.1. Such materials have a relevance, however, to traceability of
measurements since they effectively represent a sample for which the correct
answer is universally accepted. In this case, measurements are traced back to
the certified reference rather than an SI unit but provide the same basis in
that they establish comparability between different laboratories.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is particularly common practice in
chemical analysis where, strictly speaking, the fundamental SI unit is the
mole. However, realization of the mole for every analytical target is hardly a
practical proposition so the certified reference material serves as a suitable
alternative.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">However, it is important to understand
that under ISO 17025 the use of certified reference material to show that
measurements are acceptably accurate is not substitute for traceable
calibration of instrumentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.4.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Understanding
the hierarchy of reference materials</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A reference material is any material or
substance where one or more property values are sufficiently homogenous and
well accepted that they can be used for checking methods or apparatus. Two key
types of reference materials are (a) single compounds or items of established
purity or properties and (b) matrix references which are specific types of samples
where accepted values of one or more determinands have been established.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The key to the reference materials is in
the acceptance. The highest level of acceptance is a certified reference
material (CRM) but even this term is somewhat variable in meaning. Strictly
speaking, the only certified reference material of impeccable pedigree is one
complying with the definition of a CRM is ISO Guide 30, which means one
produced according to ISO Guide 35 by an organization complying with ISO Guide
34 and where the certificate complies with ISO Guide 31. The problem at present
is that there is no accreditation system against these ISO Guide, which leaves the
purchaser of reference materials with the responsibility of assessing
compliance directly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">What happens in practice is that
suppliers of commercial reference materials make an evaluation, and purchasers
rely on credibility of the supplier and on the content of the certificates
provided to give confidence that the values quoted for the reference materials
are reliable. Whether the reference material comes with enough information to
enable it to be classed as a certified reference material (CRM) or only as a
reference material (RM) is a matter of interpretation. The basis of any supplier’s
interpretation of the terms can normally be found in their catalogue. Note that
in the US the terms NIST Reference Material or Standard Reference Material
(SRM) are generally regarded as equivalent to CRM.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In practice, a reference material
obtained from reliable organization, such as NIST, EU Community Bureau of
Reference or the United Kingdom Laboratory of the Government Chemist (LGC),
will be very widely recognized and can be regarded as a reliable basis for
checking the accuracy of methods.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Some
other calibration issues.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.5.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">In–house
Calibration</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is acceptable for testing
laboratories to be self–sufficient in calibration and not to use any external
calibration services for their equipment. They will still, of course, need to
interact with the international metrology system to achieve traceability. This
will usually mean holding traceable calibrated references to be used as the
basis of the in–house calibration system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For example, a testing laboratory might
well hold a master reference thermometer which has calibration certificate
issued by an accredited calibration laboratory. The laboratory could then use
this to calibrate all its working thermometers according to a documented
procedure. The body assessing the laboratory as a testing facility would
include in its assessment an evaluation of the internal calibration system for
thermometers and would need to be satisfied on the following points:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l36 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
the reference thermometers were acceptably and traceably calibrated by a body
recognized by the assessment body as providing adequate calibration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l36 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
a sound and documented procedure was in place for carrying out calibration of
working thermometers and the adequate quality controls were applied.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l36 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
staff carrying out the internal calibrations were properly trained and seen to
be competent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l36 level1 lfo33; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">That
there were auditable records showing that all these criteria were being met on
a routine basis.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Note, too, that the internal calibration
would also have to be subject to an evaluation of its uncertainty by the
laboratory just as though it were carried out by an external accredited
calibration service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In practice, laboratories typically
carry out some calibrations in–house; thermometers, spectrometers, and simple
equipment, such as pH meters and conductivity meters, are examples. However,
more complex calibrations, and especially those requiring expensive references
which are themselves expensive to recalibrate, are typically carried out by
outside services. For example, balance calibration is quite complex, needs only
to be done fully once a year and needs expensive weights which have themselves
to be calibrated annually. It is, therefore, more economical in most situations
to use a commercial calibration service.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Another point to consider is the
question of adjustment of equipment found out of calibration. This can be a
skill and may well be outside the capability of the laboratory. Modern balances
are a case in point. In these circumstances, the use of a service which
calibrates and can, if necessary, service and adjust is likely to be an
attractive option.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.5.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Intervals
between calibrations</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each laboratory must have a policy for
determining calibration intervals, the object being to ensure that
re–calibration takes place before the previous calibration has deteriorated to
the point where the validity of the measurement is called into question.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">To some extent, routine quality control
checks will provide information which could reveal instruments drifting out of
calibration. However, wherever practicable, the laboratory should institute a
regime for verification of calibration of equipment between formal calibration
intervals to detect unexpected drift or malfunction. This is particularly
important for key items such as balances where a loss in calibration would have
a far-reaching consequence.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where it is not possible to carry out
any simple routine verification to confirm that calibration is maintained, the
laboratory will have to rely on setting specific calibration intervals. In the
first instance, the laboratory sets an initial calibration interval based on
the manufacturer’s recommendations, the heaviness of use of the instrument, the
accuracy required, the perceived risk of a loss of calibration and the
magnitude of the impact, and local experience of similar instruments. The
calibration is checked at the end of this interval and, if it is still correct,
the interval is confirmed as adequate. Alternatively, the interval is reduced
by 50% if the check shows that re–calibration is required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This process is continued until an
appropriate and adequate interval is arrived at. Records must be kept so that,
if necessary, the laboratory can justify the interval chosen.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The process may, conversely, provide
evidence of the stability of equipment and hence a justification for reducing
the frequency of calibration relative to the original estimate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Whatever the strategy for deciding
calibration intervals, it must be consistent and documented. It should also consider
that it is not unusual for accreditation bodies to insist on minimum
calibration intervals for some equipment, for example balances, which are
typically calibrated annually. In some cases, the accreditation body is
prepared to consider relaxations to longer calibration intervals, but the
laboratory would have to provide convincing evidence that data validity is not
being compromised by extending the interval.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It should also be borne in mind that
some test method, for example construction materials testing, include
requirements for verification of equipment calibration at specific intervals.
These intervals must be complied with, or the test method will be invalid.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.5.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Relaxation
of calibration requirements</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some relaxation on the traceability of
calibrations is apparently permitted in ISO 17025 by paragraph 5.6.2.2.1, but
only with testing laboratories. If it can be established that calibration
uncertainty “contributes little to the total uncertainty of the test result,”
then traceable calibration is not required and other methods of demonstrating
confidence in the equipment may be adopted.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In practice, this is not really a
dispensation at all since there is still a requirement to show that the
equipment provides the necessary uncertainty of measurement, and it is
difficult to see how this can be done without at least some calibration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In any case, accreditation bodies tend
to take a narrow view of the traceability of calibrations, and it is not
recommended that this clause be relied upon as an easy excuse to avoid
traceable calibration.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><span style="font-size: medium;"><!--[if !supportLists]--><span style="color: #01ffff;"><span><b><span style="font-family: "Palatino Linotype", serif;">10.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b><!--[endif]--><span dir="LTR"></span></span><b><span style="font-family: "Palatino Linotype", serif;"><span>Administration
of work and sample tracking</span></span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">10.1<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have procedure for logging samples into your laboratory?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Are
all samples uniquely numbered as soon as practicable after receipt?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Does
your system ensure that samples are stored securely and in a way that will
preserve them against changes which may affect data generated form them?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a system for ensuring that the procedures required to be carried out
on samples are clearly communicated to laboratory staff?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a procedure to ensure reports are checked to make sure they correspond
to the raw data?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">10.2<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Receipt of
samples or calibration items</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Before any work is begun, the contract
review process described in Section 7.3 must be complete. There must also be a
check to confirm that any test or calibration items are appropriate for the
procedure and in suitable condition.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The documentation on sample/item receipt
should specify which staff are authorized to receive and record items. The
usual practice is to keep a receipt register. The information recorded should
include details of the condition of items on receipts and should identify the
person making the register entry.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The “condition” should cover any
parameters which may affect the results, for example temperature, whether
bottles are full or partially full, and any information on breakages or damage,
spillages, leaks, or lost labels.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The person receiving the items should
also be responsible for examining them to ensure that they are suitable for the
intended test or calibration. If there are any problems, action must be taken to
ensure that now work is done before the problems are resolved with the client.
A record must be kept of any communications with the client, as described in
section 7.3, since such communications involve amendment to the contract
review.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It should also be emphasized in the
quality documentation that no work must be done until all matter of concern has
been brought to the client’s attention and clarified to mutual satisfaction, i.e.,
the contract review is complete. These may include problems with the items
themselves or any lack of clarity about the work required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">10.3<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Identification
and Storage of Items</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory should have a clearly
documented policy on where items are to be stored. This may involve several
storage locations for different types of items, but these should be clearly
specified. Each storage location should have a book or record form in which
items can be signed out and back in again.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A particular type of item will be found
in the storage location or can be located by reference to the book. The record
in the book should identify the person taking the item and the date and time of
removal. Similarly, return date and time should be recorded, if appropriate.
The object is to create a complete history of the custody of the item.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All items must have a unique identifier
which stays with them throughout their time in the laboratory. Although the
standard does not actually require sample numbers, it is generally difficult to
persuade assessors that, for example, using the client’s sample description as
an identifier provides unique identification. Bear in mind that the
“uniqueness” must be retained over the period for which the laboratory retains
its records, so a system over which the laboratory does not have direct control
is immediately suspect as possibly leading to duplication.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For the same reason, it is not adequate
to retain a numbering system which repeats cyclically. It is not uncommon for
laboratories to set sample number to unity at the start of a calendar year
since they only expect to keep samples for a very short period. The records,
however, will have much longer currency, which must be allowed for in the
numbering system.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The numbering method can be chosen to
suit the requirements of the laboratory, but it must be unambiguous. The
laboratory sample number must be related to any client identification details.
The simplest way to do this is to record the laboratory number and the client’s
identification in the sample receipt records.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Both the laboratory number and the
client’s identification details will have to be included in any report sent out
– see section 13.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">10.4<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Internal information
transfer</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There must be clearly documented
procedure which shows exactly how the client’s requirements are passed to the
person who will do the test or calibration work. This should normally be done
in writing so that a traceable record is kept. This requirement is met, for
example, by the person allocating work completing a worksheet and passing it to
the laboratory staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Once the work is complete, there must be
a documented procedure showing how the data is checked and transcribed to the final
report. It should be clear who is responsible for deciding whether the quality
control criteria have been met and who can release the data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is no problem with having check
performed at different levels in the management/technical structure, but the
system must be clear, and the quality control information must be recorded
explicitly. A system where individual staff are given the initial
responsibility of verifying that the data meets the quality control criteria is
perfectly consistently available to all who carry out the checks. This may be
achieved, for example, by including details of the acceptance criteria in the
methods documentation. However, the responsibility for the final release of
data to clients must reside with clearly identified individuals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">10.5<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Compilation of
reports</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The procedure for compiling reports must
be clearly documented, showing exactly which staff is responsible for putting
reports together and authorizing their release. There must be a documented
requirement that all reports are checked against the raw data and the client’s
instructions before being issued. This should be done by the person authorizing
release of the report sine they take responsibility for its contents. All
checks should be recorded. Normally, this is achieved by the person carrying
out the check signing and dating the documents involved.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">10.6<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Retention and
Disposal of Items</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is only an issue for testing
laboratories since items sent for calibration are invariably returned to the
client. In this case, the laboratory’s obligation is to ensure that items are
properly packed and transported to maintain the integrity of the calibration.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Testing laboratories should have a clear
policy on how long samples are kept. Wherever possible, samples should be
retained for a period after the report is issued in case there are any queries
which might be resolved by re–test. In the case of some determinands, of
course, this is impractical in any case so the laboratory should reserve the
right to dispose of samples immediately if their retention makes no technical
sense.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 specifies no minimum period
for sample retention but one month after report issue is widely used where it
is technically meaningful to re–test sample. Clients should be made aware, for
example through the laboratory’s standard terms of business, what the sample
retention policy is so that there no misunderstandings.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It should be clearly documented who may
authorize sample disposal and all disposals should be recorded.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><span style="font-size: medium;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">11.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif;">Recording
of results and associated data</span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">11.1<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Does
your system ensure that all observations are recorded at the time when they are
made?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">In
this record, is the raw data always preserved so that any problems can be
investigated?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a policy on how amendments to entries on laboratory records are to be
made?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Does
the system allow the person making any record to be identified?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">11.2<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">General
principles of data recording</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">No set format for the recording of
results is specified in the standard. Laboratories may adopt where system
suites their needs. The two usual options are the use of worksheets or the use
of laboratory notebooks, either personal or method specific. In some instances,
both systems can operate together.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Laboratories are also increasingly
entering data directly into computer systems. The control of such systems is
dealt with explicitly in Section 12.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The overall requirements from quality
point of view are that data must be recorded at the time of observations and in
such a way that there is a complete audit trail so that errors can be traced,
and work can be repeated in a manner as near to the original as possible. It
must be possible to trace a result to the person who made the measurement and
the equipment used and to identify precisely the method used. This means that
the audit loop can be closed, making it possible to check that the work was
done by a trained member of staff, using appropriate methods, on correctly
functioning and calibrated equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The record must be complete so there
should be no use of scraps of papers. All data, calculations and observations
must go on worksheets or in notebooks in non–water soluble ink or ball point
pen. Pencils and water soluble felt tip pens should be banned from the
laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Corrections to notebooks and worksheets
must be made in such a way that the original version can be read. The approved
method is to cross out the original with a single line and write in the
corrected version as near to it as possible. Corrections should be initialled
and should, ideally, carry a note explaining the reason for the correction.
Correction fluids should be banned from the laboratory completely.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">11.3<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Worksheets</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Worksheets are the best strategy for the
routine laboratory. There should be a worksheet for each test or group of
related tests. The worksheet should not only prove space for recording results
but should also require all calculations to be done on it. In fact, wherever
possible, the calculations should be laid out in outline ready for the
variables and the results to be written in.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This should include all calculations,
even those required to calculate dilution of standards and weights derived by
difference. The object is to have as much information as possible to support
quality assurance and to provide for error tracking. A well-designed worksheet
should also reduce the likelihood of errors.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff; font-family: Palatino Linotype, serif;"><span style="font-size: 12pt;">All entries must be </span>initialed<span style="font-size: 12pt;">, and all
calculations should, wherever possible, be checked and </span>initialed<span style="font-size: 12pt;"> by the
checker. The checking of all calculations is sometimes resisted by laboratories
on the grounds that it duplicates work. ISO 17025 is specific in requiring
calculations to be checked although it does not actually say that this must be
by a second person. Whatever policy is adopted, the onus of proof will be on
the laboratory to demonstrate that there is not a substantial error rate in
calculations. One possible strategy is to check a sample percentage of calculations
and, hopefully, as a result to build up a body of evidence that errors are not
being made. However, not all assessors will find this acceptable.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Finally, the worksheets should have
space for signature by whoever is responsible for final quality control checks
and a space to indicate pass or fail. This effectively releases data for
inclusion in reports.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">11.4<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Notebooks</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If notebooks are used, they must be
properly controlled they constitute the raw data record belonging to the
laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each book should be numbered. The
Laboratory Manager should keep a record of the holder or use of each book. The
books should have numbered pages so that a record can be referenced by notebook
number and page and so that page cannot be torn out without being detected.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Staff should not be allowed to remove
notebook from the laboratory except for field work, and full books should be
returned to management for archiving before a new one is issued.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If the notebook system operated in
conjunction with worksheets, then the worksheets should have a section for
recording cross references to notebooks: book number and page number.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Notebooks in isolation are not the ideal
solution for use in a routine testing laboratory but can be as useful adjunct
to worksheets.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">One problem which can arise with
notebooks and for that matter, with worksheets is that staff, anxious to be
neat and tidy, record data in rough and then copy it over later. Strictly
speaking, this practice is not a non–conformance as such, provided the rough
notes, which now constitute the raw data, are retained as part of the
laboratory record. It would also be necessary to have checks on the accuracy of
the transfer of the data from the rough notes.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is preferable, however, for a
laboratory to forbid this type of practice and to insist upon all data being
recorded directly on worksheets or in official notebooks. This ensures consistency
in practice and leaves no ambiguity about what constitutes the raw data. It
also eliminates a data transfer step, which is a potential source of error.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">11.5<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Other types of
data</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Many instruments now produce printed
output. This should always be retained as part of the raw data archive.
Ideally, it should be attached to worksheets but if this is impracticable it
should be filed in a systematic manner so that it can be readily retrieved.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The printout must show the sample number
and the operator of the instrument. Ideally, the operator should initial it to
prevent misrepresentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any other relevant paperwork produced
should be traceable in the same way and must be marked with the sample number
and the name of the person generating it.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where instruments record data in
computer files, these should, preferably, have provision for recording the
operator and the sample number to which the file refers. If this is not
accommodated, it will be necessary to institute a record book which is filled
in with the sample number, the operator, and the computer file identifier.
Alternatively, the same information might be accommodated on worksheets or in
notebooks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All computer files will need to be
secured by appropriate backup regimes. See section 12.9 for details.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><span style="font-size: medium;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif;">Computer
Systems</span></b></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.1<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have control of what software may be loaded onto any of your computers?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Are
all computer systems, including software, checked to ensure that they record
and process data correctly?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Is
all software secured against unauthorized changes?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have records showing when software was updated and that checks were made on
its correct functioning after update?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a procedure for regular backup of data held on computers?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.2<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">General Issues</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Computers and associated software can
obviously affect data validity and so need to be properly managed and
controlled, whether they be part of instrumentation or systems simply used to
store and process data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All computers must be introduced into
use through a controlled system and must be subject to checks for correct
functioning before being placed in routine use. This applies to all hardware
and software and especially to software written in–house or applications
developed on spreadsheets, for example. There should be records of the checks
used to ensure correct functioning, as with any other piece of equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.3<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Control of
Software</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a defined person who is
responsible for authorizing any software to be used in the laboratory. This person
must ensure that it is checked to show that it does not corrupt data or other
information before it is released for use. This requirement must not apply only
to new software but also to any updates or modifications. The responsible
person should be the Laboratory Manager or someone to whom the responsibility
is delegated by the Laboratory Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is no reason why staff cannot set
up spreadsheets, for example to carry out routine calculations and data
processing, but they must have these checked and authorized before use. It is
not acceptable to have staff setting up ad hoc applications and using them without
their being accepted by the Laboratory management as suitable for their
purpose. One issue which must be addressed, however, is the question of whether
spreadsheets and similar software which can contain set–up calculations may be
corrupted and so lead to wrong results. Wherever possible, spreadsheets must be
protected from alterations by using passwords reserved to the management. Where
this is not possible, a set of sample data must be available, which can be
loaded before the spreadsheet is used, to check that the calculated values are
determined correctly.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">To ensure that the system for
controlling software is effective and can be audited, each computer should have
a log which shows the hardware and software installed. Any new software or
modifications to existing software, including new releases of commercial
packages, should be recorded in the log with the date when they came into use. It
is the possible to determine which version of the software was in use at any time,
should an error need to be traced. There should be regular audits of the actual
software installed against the log and any authorized software should be
removed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It must also be possible to recreate the
previous versions of any software in case an error or query arises, and it is
necessary to determine whether the software was responsible. The simplest way
to provide this backtracking facility is to ensure that, at each update, a copy
of the previous version is retained on a removable medium such as tape or disc.
Some larger commercial packages have a built–in facility to backtrack and this
can be used, if available.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.4<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Computer
Networks</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Increasingly, laboratories use local
area computer networks, especially if they are operating Laboratory Information
Management Systems (LIMS). Such networks can make control of software easier
since work areas can be established with restricted access and often with
different levels of access. These networks should be exploited to control, for
example, who can write new files to the network server. In general, the network
should be operated as described above. For stand-alone computers, there should
be a log of the software installed, and updates and new installations should be
controlled as described.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Care will need to be taken where the
workstation machines also have local disc drives. The laboratory will need to
have a policy on whether local software will be permitted. If the local
software is in use, then each workstation will need its own log in addition to
the network log. If local software is not authorized, the audits should check
if any unauthorized material has been loaded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.5<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Computer systems
managed by other departments.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It often happens that the laboratory
management does not have direct control of the network servers. These may be
part of a general company network, for example, and so under the control of a
computer section. The laboratory management will need to demonstrate assessors
that it knows what is being done by the network management on its behalf and
that is informed of any software updates so that it can carry out checks on
correct functioning.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The most convincing way for the
laboratory to demonstrate it control is to have written agreement between the
laboratory and the network management which specifies the division of
responsibilities. This should cover at least the following points:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l47 level1 lfo37; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
network management must agree to consult the laboratory management and obtain
its agreement to make new software accessible to laboratory staff. If
necessary, the laboratory management must reserve the right to carry out checks
on the software before accepting it.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l47 level1 lfo37; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
network management must agree to inform the laboratory if it intends to update
or otherwise amend any software used by the laboratory. It should be clear what
checks the network management will carry out on the laboratory’s behalf and
what checks will be carried out by the laboratory before the software revision
is released. The key is to clearly define the responsibilities of each party to
avoid inadequate checks when both parties suppose the other to be responsible.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l47 level1 lfo37; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
responsibility for providing the ability the backtrack to the previous version
of the software should be clearly agreed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l47 level1 lfo37; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
responsibility for keeping the log of software and updates should be agreed.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l47 level1 lfo37; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">There
should be a clear mode and level of communication between the two parties. In
particular, the network management must know who is authorized to request software
changes on behalf of the laboratory and must not respond to requests from
unauthorized members of the laboratory staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l47 level1 lfo37; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
arrangement for backing up the laboratory’s data on the network must be agreed.
See section 12.9 for general guidance on backing up.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.6<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Data integrity
on computers</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where laboratory handles data on
computers, there are considerations, mainly of data security and control of
data alterations. From time to time here will be a need, for perfectly
legitimate reasons, for a laboratory to alter data which has been recorded.
Entries may, for example, have been erroneously or quality control results may
have indicated a need for a repeat measurement which then produces a different
result.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The first thing that the laboratory should
decide is whether the computer record constitutes the raw date, i.e., the data
recorded at the time of the observation. This will only be the case where the
data is logged into the computer directly from instruments or is entered at the
bench. If data is recorded in notebooks or on worksheets prior to transfer to
the computer, then these paper records are the raw data. Raw data must be
preserved as part of the laboratory record. If there is manual transfer to the
computer, then the laboratory will have to convince assessors that there are
adequate safeguards to check that this is done correctly and that, once the
transfer is completed and checked, any alterations to data are under control
and in compliance with the requirements of the standard.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Manual entry of data into computers is
clearly a potential source of error. Ideally, all such transfers should be
checked by a second person. In critical cases, double entry of data can be
practiced, where the data is entered twice to create two files which can then
be compared by appropriate software. The onus will be on the laboratory to
demonstrate to assessors that it takes reasonable steps to check that data is
entered correctly. At the very least, the laboratory should check a proportion
of the data entered and, hopefully, build up a body of information that
demonstrates that significant errors are not being made.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A more fundamental problem arises with
computers when it is possible to alter data without leaving a record of the
alteration or of the original entry. This contravenes basic requirements that
all alterations must be traceable to the person carrying them out and must be
made in such a way that the original value is retrievable. Software
specifically written for laboratory purposes usually incorporates an audit
trail which logs alterations and the identity of the person making them through
their username. Such software will normally also retain a record of the
original entry and may even require entry of the reason for making the change.
Where there is an audit trail of this type, the laboratory will meet the
requirements of the standard provided there is a mechanism for monitoring the
audit trail as part of the quality checking procedure.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Software not designed specifically for
laboratories is unlikely to contain this audit trail facility and so other
steps may need to be taken. The simplest option is to make a rule that all
alterations must be recorded in a paper log. This should show the identity of
the person making the alteration, the date of alteration and the old and new
values. Ideally, there should also be facilities to record the reason for the
change. Such a system, although simple, is not likely to be easy to present as
compliant with the standard since it is, in most situations, not auditable. If
someone make an alteration to raw data in a computer and fails to fill in the
log, then the failure cannot be detected. On the other hand, if the raw data
exists on a work sheet, there will either be a discrepancy between the work
sheet and the computer record, or the work sheet will show an alteration to the
new value. In this case, the system is auditable and acceptable. Note here the
critical need to be clear about what constitutes the raw data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If data in the computer can be protected
by the software from alteration, for example by being given read–only status
when entered, then the use of a paper log of amendments is must more secure.
The laboratory should establish clear rules on who can authorize amendments to
the data, and they alone should be able to lift the read–only status of the
data and make the amendment. The authorized person is responsible for filling
in the log. Provided the authorization for alteration of data is at suitably
senior level, the assessors are likely to be satisfied. An appropriate level
would be at least senior technical staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The discussion so far has been confined
to raw data in computers, but the status of data changes as it moves through
the laboratory and the degree of protection must be greater at each step. Raw
data is first submitted to quality control scrutiny and, provided it passes, is
then available for incorporation into reports. Up to this point, alterations,
subject to the requirements for an alteration record to be generated in some
form, may be permitted to be carried out freely. However, once data has passed
the quality control fence, only the most senior staff, normally the Laboratory
Manager and designated senior professionals, should be able to authorize
changes. This implies that data in computers must be protected from
unauthorized alteration, either by being made read–only or by transfer to
computers physically accessible only to authorized persons. A laboratory cannot
comply with the requirements of ISO 17025 if quality-controlled data can be
altered freely by any member of staff, especially if no automatic audit trail
is generated. It is also important to remember that the need to alter data
after it has passed quality control automatically creates a situation where
quality incident, non–conforming work, has occurred and corrective action will
be required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The situation escalates further once
data has been released as a report. There would be a serious non–conformance if
the laboratory’s record of data failed to reflect the report content. Specific
procedures must be followed when reports must be amended, and the original and
amended data must both be available – see Section 13.6. Once data has been
reported, amendments to the laboratory’s archive must only be allowed at the
highest level, by the Quality Manager and senior technical management, and so
data on a computer must be totally protected from change by any other staff. It
must also be impossible to generate a new version of the original report with
altered data without meeting the requirements of the standard for report
amendment – see Section 13.6. The need for report amendments automatically
requires a quality incident record and corrective actions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Beware of falling into following common
trap: Data has been altered on a computer but not on the corresponding work
sheet. If there is no record or audit trail for the alteration on the computer,
a serious non– compliance arises since it is impossible to tell which data is
valid. An initialled alteration on the work sheet to bring it into line with
the computer value would have solved the problem.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.7<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Computers which
are a part of instrumentation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Computers which control or collect data
from instrumentation should be treated as a part of the instrument and be
checked as part of the operation of the overall system. Software changes and
upgrades should be treated in the same manner as any other modification to the instrument
and must be checked for satisfactory functioning before their release for
routine use.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Care should be taken when instruments
are serviced by suppliers since service engineers not infrequently load
software patches and modifications. The laboratory management must make it
clear to the service agency that it needs to be informed of any software
changes so that they can be checked and recorded in the instrument log.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Computers attached to instruments can
provide an excellent means of retaining raw data in a compact form. For
example, chromatography data can be a problem to store as hard copy but
archives on tape or compact disc are highly compact. However, secure backup
regimes are essential to protect the data – see Section 12.9.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.8<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Some
considerations on Laboratory Information Management Systems (LIMS)</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">LIM systems are becoming increasingly
common and can assist greatly in the operation of a quality management system. It
is even possible to obtain systems which incorporate records of calibration
intervals and training review in a manner that will prevent the entry of data
generated on instruments past their calibration date or by staff whose training
review is overdue.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some points about LIM systems are worth
noting, however, since they sometimes introduce the possibility of quality
anomalies and may not be providing exactly what the laboratory management
supposes they are.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l13 level1 lfo38; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Most
LIM systems automatically stamp data entries with the identity of the person
entering the data. The information is derived from the person’s computer username
when they log on to the system. In this case, it is essential that the
laboratory enforces a rule that staff must only use terminals which they have
logged into under their own name. They must not just use any terminal which
happens to be logged on and available or the audit trail is destroyed. There
should be an absolute rule that no terminals are left logged on and unattended;
in any case, this has security implications. In most systems it is possible to
set terminals to log off automatically after a period of inactivity. This
should be exploited.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l13 level1 lfo38; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">It
is not unusual for LIMS to only identify the person entering data and to
designate them as analyst. In many practical laboratory situations, data may be
entered by someone other than the actual analyst. The laboratory needs to be clear
about how to achieve an audit trail which identifies the person carrying out
the analysis. If analysts always enter their own data, then the LIMS can
provide the trail very simply. If this is not the case, the laboratory must
recognize that it is the person entering the data that the LIMS actually identifies
and must have some other means of providing the audit trail to the analyst, for
example, by initialling work sheets. In many instances, it is simply a matter
of making the position clear and communicating it properly, especially to
assessors. Increasingly, LIMS permit separate identification of the analyst and
the person entering the data. This provides maximum flexibility and should be
made available whenever possible.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">12.9<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Backup of data
on computers</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This is obviously a critical area. It is
also subject to the strange human perception of computers which leads to mildly
illogical stances where one copy of data on paper is generally regarded as
perfectly acceptable but once data is on machine readable media backup copies
are required. The lack of logic is not, I hasten to add, in requiring backup of
computers but in being happy with single paper copies!</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A laboratory is under an obligation to
ensure that it protects any data which it holds, especially if this is a raw
data or an essential part of the audit trail. Where a laboratory has raw data
in computer, the backup regime must be extremely rigorous.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The policy for backup should be such
that, should there be a system failure where data not yet backed up irrevocably
lost, the laboratory would be able to recover it, either from worksheets or by
repeating the tests. In the extreme situation where a laboratory is carrying
out work which, by its nature, cannot be repeated and where the only copy of
the data is on computer, backup will need to be very frequent. A common strategy
is for laboratories with LIMS to have dual disks drives on the main computer or
network server, or even dual servers, and for all data to be recorded directly
on both. This is further supplemented by regular tape or optical disc backups,
sometimes twice a day.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Most laboratories are not so exposed,
and a daily backup will be sufficient; a good rule of thumb is to ensure that
all data is backed up at the end of each working day and transferred to secure
storage. This storage should be separated from the laboratory area by a fire
break and, ideally, be provided with a fireproof safe designed for data
storage. Fireproof safes designed for documents are not suitable since they
reach too high a temperature to protect magnetic media.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If data must be kept in the laboratory,
then a data safe is essential, and its use must be rigorously enforced.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">When data is removed from online access,
for example to regenerate capacity on the working computers, then two copies
should be made, and one stored off–site or as far from the laboratory as
possible. The laboratory will need to be in a proposition to retrieve the
archived data with reasonable ease, so it is advisable to ensure that some
index of the archive is generate. Good LIMS systems will provide this
automatically and will retain the index as part of the online system, enabling
rapid identification of the location of the archived data for a particular sample.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The archive or backup medium can be any
medium is convenient. Tape or floppy discs are perfectly acceptable but the
increasing convenience of optical storage, for example writable CD and DVD
drives, is now proving popular and such facility should certainly be seriously
considered as part of an LIMS.</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">13.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b><!--[endif]--><span dir="LTR"></span></span><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: medium;">Reporting
Requirements</span></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">13.1<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a defined report format?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Does
this comply with the detailed requirements of ISO 17025?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Does
your system ensure reports always reach only those entitled to receive them?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Does
the report acknowledge subcontracted work?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a policy on how to deal with situations where it becomes apparent that
suspect data has been reported.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a clear identification of staff authorized to approve reports?</span><span style="font-family: "Palatino Linotype", serif; font-size: 12pt;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">13.2<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Report Format</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 is quite specific about what
must appear on reports from the laboratory but also has a general requirement
that the information must be reported accurately, clearly, unambiguously, and
objectively. It must also be in accordance with any specific instructions in
standard test or calibration methods specifications.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is a relaxation of this if a
laboratory is reporting within its own organization or in the case of a
specific written agreement with a client. In these circumstances, the report
may be abbreviated but, nonetheless, all the information required by the normal
report format must still be available within the laboratory. Normally, the
written agreement with clients to report in an abbreviated format should be
concluded as part of contract review – see Section 7.3.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Requirements for test and calibration
reports differ slightly but the following are common factors:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
Title: Test Report, Calibration Certificate, Test Certificate and Calibration
Report are all mentioned as appropriate terms in the standard but there is no
compulsion to use these specific terms.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
name and address of the laboratory and the name and address of the client if
the test or calibration was carried out on site the location of the actual work
must also appear.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
serial number or similar unique identification for the report which should
appear on each page together with pagination in the form (page x of x) an
alternative way of indicating the total number of pages is also permitted
provided it allows the user to be certain about whether they have a complete
document.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
client’s identification details for the samples or calibration items and the
identifiers used by the laboratory, for example sample numbers. There should
also be a brief description of the items and a note of their condition.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
date of receipt of the items and the date(s) of testing or calibration.
Strictly speaking, the date of receipt is only required when it is critical to
the validity of the results, for example if testing needs to be done within a
certain time of sampling or where samples or calibration items require conditioning
before being worked on. In practice, there are few occasions where the date of
receipt has no relevance, so it is recommended that it be incorporate
routinely.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Identification
of the method used and any sampling plan or method which is relevant to the
data. These may be direct reference to a standard specification or may refer to
a documented in–house method. In the latter case, a brief outline of the
procedure, including any sampling methods, should be included. In practice,
many accreditation bodies permit a generic statement indicating that the
laboratory’s standard procedures were used and offering the client a reference
list on request.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
note of any deviations from a standard method and any environmental conditions
which may bear upon the results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
test or calibration results themselves with units.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">9.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
name, position and signature or other identification of the person accepting
responsibility for the report and the report’s date of issue; it is recommended
that the person accepting responsibility initials each page of the report where
this is practicable. It is up to the laboratory to decide who is identified as
having authority to release data, i.e., sign reports. The onus will be to
satisfy assessors that the person(s) so authorized have the appropriate skills
to evaluate the data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">10.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
relevant, a statement that the results only apply to the items tested or
calibrated. This is generally required in the case of product testing to
prevent the results being applied inappropriately in support of general product
or batch certification.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l29 level1 lfo40; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">11.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Preferably,
a statement that the report shall not be reproduced, except in full, without
the written permission of the laboratory.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In addition to these general
requirements, there are the following specific requirements for test reports:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l26 level1 lfo41; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Details
of any deviations from the standard test method and information on any relevant
factors such as environmental conditions.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l26 level1 lfo41; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
relevant, a statement on compliance/non–compliance with requirements or
specifications. The key test of relevance here is whether the client requires
the information. This will depend on the question asked by the client. If the
request is to test for compliance with a specific requirement, then there is
clear relevance. If the request is simply for data, then the statement does not
have to be volunteered.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l26 level1 lfo41; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
applicable, a statement of the uncertainty of the result; this is generally
regarded as applicable were requested by the client, when it is relevant to the
application of the test results and when uncertainty affects compliance with a
specification. It is hard to see a situation where uncertainty does not affect
compliance with a specification, but most accreditation bodies are currently
not taking such a rigorous view. Note that even if uncertainty is not required
in the test report, the laboratory is still required to have estimated it. This
is a completely independent requirement.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l26 level1 lfo41; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
appropriate and needed, opinions and interpretations. This is a developing area
as ISO 17025 is the first standard for laboratory systems which covers
requirements for opinions and interpretations. Previous practice was to exclude
them from the standard and hence from the scope of accreditation. A disclaimer
was then required when reports contained opinions and interpretations. Many
accreditation bodies are still operating in this way as an interim measure
while they develop procedures for assessing laboratory systems for managing
quality of opinions and interpretations. The “when needed” requirement is,
however, regarded as being relevant to situations where the opinion or
interpretation effectively constitutes the result. Examples include forensic
investigations where the question posed may be a goodness of fit and this based
on various test results from which a conclusion needs to be drawn. Whether an
opinion or interpretation is required is an ideal issue to be clarified at
contract review.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l26 level1 lfo41; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Any
other specific information which may be specified by the method or requested by
clients.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l26 level1 lfo41; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reference
to the method of sampling, the items samples, the date of sampling, any
relevant environmental conditions, and other relevant factors when the
laboratory undertakes sampling, and an understanding is relevant to
interpretation of the results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The additional requirements for
calibration reports are as follows:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo42; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
record of any environmental conditions which have an influence on the
measurement results. This normally means temperature, possibly pressure and
sometimes humidity.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo42; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">The
uncertainty of measurement. Not that this is compulsory in calibration reports.
The only exception is when a report is made about compliance or non–compliance
with an identified meteorological specification. In this case, the uncertainty must
be considered when determining the compliance, so it is not explicitly needed
in the report. However, the laboratory must still have a record of the
uncertainty and the data used to determine compliance.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo42; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Evidence
of traceability. This normally requires details of the references used and
cross reference to their calibrations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo42; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Where
an instrument has been adjusted, the results before and after adjustment. This
allows the client to estimate drift and perhaps to review calibration
intervals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l7 level1 lfo42; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Unless
there is a legal requirement, calibration reports should not carry any
recommendations on a re–calibration interval or date since this might be taken
to imply that the calibration has a specific time validity. Clearly the
laboratory cannot offer any such guarantee once the item calibrated leaves its
custody. This prohibition is relaxed if the client asks for a recommendation,
but the laboratory should make it clear at contract review and in the wording
of the report that this is only a recommendation and that no guarantees are
being offered that the calibration will remain valid for the stated period.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Other factors to be borne in mind when
reporting is the inclusion of sub–contracted data in reports and the question
of reports which contain results for work not included in the laboratory’s
scope of accreditation. The general principle enforced by accreditation bodies
is that these results must be identified clearly and that the laboratory must
not seek to misrepresent its scope of accreditation or to represent
sub–contracted data as having been generated in–house. In the case of
calibration laboratories, there is an absolute requirement to supply the client
with the report issued by a subcontractor, but this not required from testing
laboratories. See Section 15 for further discussion of sub–contracting.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 has nothing to say about
reporting tests and calibrations not covered by the scope of accreditation
since it does not address the issue of limited scope of accreditation at all.
Perversely, the standard is written on the assumption that everything which the
laboratory does is within the scope. This is rarely the case. The consequences
of this deficiency in the standard are generally dealt with by regulations
formulated by the accreditation body to prevent misrepresentation of the scope
and hence the areas of activity which they underwrite.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Some accreditation bodies require that a
minimum proportion of the results, for example 50%, are within the scope of
accreditation before their logo or reference to accreditation can be used. More
commonly, a disclaimer, with clear marking of non–scope data is permitted.
However, if none of the reported data is within the scope of accreditation, the
logo of the accreditation body and/or reference to accreditation may never be
used on the report.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">13.3<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Some further
comments on opinions and interpretations</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Laboratories are required to be able to
show that they have a documented basis on which professional judgements are
made and that the qualifications and experience of those making them are
appropriate.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Appropriate information would be
references to any general requirements, standards, technical requirements, or
contractual specifications which are being used as a basis for the judgement.
In the case of judgements based on individual’s professional experience,
assessors will need to be satisfied, based on the staff records, that the
person making the judgement is appropriately qualified. Wherever possible,
laboratories should have guidelines for any routine interpretations and
judgements which must be made to ensure that they are made consistently over
time and by different individuals.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">13.4<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Authorization of
Reports</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Authorization of reports can be a
problem area. The ideal situation is that all reports are signed documents. In
practice, commercial laboratories often must give data over the telephone or by
fax. The status of faxed documents, even if signed, varies in different legal
systems as does that of emails. The wisest strategy is to make it clear to
clients, and in the laboratory’s quality documentation, that the only
definitive report is the signed original transmitted in hard copy. All other
transmissions, fax, electronic or verbal, are subject to confirmation. This
should not, however, be a substitute for ensuring that data is only
communicated after proper release. The laboratory should have a clear policy,
for instance, on which staff are authorized to give results over the telephone,
and this should only be permitted once the data has undergone all quality
checks and is ready for inclusion in a formal report.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Reports generated by computer are
another area where careful control is required. Increasingly, laboratories
produce large numbers of reports directly from laboratory computer systems and
often in quantities where signing each report is totally impractical. ISO 17025
permits authorization by means other than a signature, but the report must sill
identify an individual who take responsibility for the data and his or her
position.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of reports generated from a
computer, it is essential to have security such that only authorized persons
can generate reports. It is also essential to ensure that, once a report has
been generated, it is not possible for an unauthorized person to alter the data
in the computer and then to generate a changed version of the report. The
security must be such that the rules for report amendments discussed in section
13.6 are observed, which effectively means that once a report is issued to a
client the laboratory’s copy, even if a computer file, must never be altered.
Amendment requires that a completely new report is issued. The security can be
achieved physically but assessors will normally expect to see appropriate
software protection. Section 12 deals specifically with the use of computers
and ways of providing appropriate safeguards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The format and content of reports will
come under very close scrutiny by accreditation bodies. It is the report, after
all, which carries the accreditation body’s log and, hence, its stamp of
approval. It is in the interests of neither the accreditation body nor the
accredited laboratories that this approval appears on an inadequate document.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">13.5<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Transmission of
Reports</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Normally, reports will be sent by post
to the client’s address. Where other means, for example, fax, telephone, or
electronic transfers are used, there must be a documented policy to preserve
confidentiality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This should normally specify that the
client must agree, in writing, to the transmission and, where the telephone is
used, that results should only be given to an individual who can be recognized
by the laboratory as entitled to the results. It is good practice for the
laboratory to require the client to confirm their own sample identifiers or
some other information related to the samples before being given the results
over the telephone to establish bona fides. Telephoned results should always be
confirmed in writing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If the client requires the results to go
to an address other than their normal address, or data is given to an
alternative telephone, fax or email location, the laboratory should ask for
confirmation of this requirement in writing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If the client requires the results to go
to an address other than their normal address, or data to be given to an
alternative telephone, fax or email location, the laboratory should ask for
confirmation of this requirement in writing.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">13.6<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Amendment of
reports</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The rules of amendment of reports, once
issued to the client, are quite specific. The original report cannot be
destroyed and expunged from the system to be replaced by an extended or
corrected version. A completely new report must be issued which complies with all
the normal reporting requirements, and it must be endorsed to show that it is
an amendment, supplement, or complete replacement of the previous version. The
laboratory must retain copies of the original and the amended versions as part
of its archive. Care is needed when report archives are computerized to ensure
that the new version does not overwrite and obliterate the original.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A need to issue an amended report will
imply a prima facie quality failure – non–conforming work – and will need
investigation and corrective action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">13.7<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Response to
reporting of suspect data</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">When the laboratory discovers a case
where suspect data has been released, for example if it emerges that an
instrument is found to be out of calibration at a regular check and it is
uncertain when it went out of calibration, the general requirement is that
clients should be notified of any such questions about the data reported to
them.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There are obviously substantial
commercial sensitivities here, and it is generally accepted that laboratories
are only required to notify clients after they have carried out a full
investigation and determined that there really is a problem.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Accreditation bodies do, however,
enforce this requirement rigorously and will not be swayed by arguments about
the commercial damage which could result from writing to clients to tell them
that their data may be wrong. Indeed, if the assessors find a problem, for
example, an un–calibrated instrument, they may well insist on notification of
all clients whose data may have been affected as part of the action to clear
the non–conformance. Note that this refers only to surveillance visits.
Assessors cannot insist on such action at initial assessment since data
released prior to accreditation is not covered by the accreditation
requirements.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">14.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b><!--[endif]--><span dir="LTR"></span></span><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: medium;">Purchasing
services and supplies</span></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">14.1<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key Questions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you take steps to control the quality of any purchased good or services which
might affect the validity of your data?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a list of approved suppliers and a policy on their selection?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you keep this list under review and remove any suppliers found to be inadequate
from a quality perspective?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a system for checking all received materials against the order
specifications?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">14.2<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Requirements</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The general requirement is that, where
the quality of any outside services or supplies may have an impact on the
quality of the data or calibrations emanating from the laboratory, there must
be procedures to ensure that the quality of services or supplies is adequate
and consistently so.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The two extremes of an approach to
quality of supplies and services are for the laboratory to check everything on
receipt or for only approved, preferably certified or accredited suppliers, to
be used and checks to be dispenses with. In practice, elements of both extremes
will be used. Laboratories have approved and trusted suppliers but also carry
out checks, often as an integral part of methods, for example reagent blanks or
calibration checks.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The onus will be on the laboratory to
demonstrate to assessors that it controls the quality of any input, service or
supply which could impact data quality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In practice, the approved supplier
position under ISO 17025 is not nearly so big an issue as it is under ISO 9001
since test and calibration methods generally contain quality control checks
which, indirectly at least, monitor materials and services obtained outside. No
laboratory is, for example, likely to want to argue that running checks, such
as reagent blanks, can be dispensed with based on the supplier’s specifications
for a reagent, however impeccable the supplier’s quality management
certification.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is when such checks are statistical
that the laboratory has to be careful about assessment of suppliers, for
example, where rather than running a blank each time a method is run, batch of
reagent is sampled and checked for suitability on receipt. The level of checks
applied will then need to be defended and the quality assurance capabilities of
the supplier will then be an issue. This may even mean different levels of
checking being applied to the same materials obtained from different sources.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">14.3<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Approved
Suppliers</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 requires policies for the
selection and use of external services and suppliers and records both suppliers
used and their quality assurance approval. In practice, this means that the
laboratory must have a list of approved suppliers with, where appropriate, a
list of the goods or services which each is approved to supply.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a policy for approving
suppliers which is normally administered by the Quality Manager. The policy
should state that, wherever possible, the laboratory will use suppliers who
hold ISO 9001 certification for their quality system, or relevant product
certification. Those with such certification would normally gain automatic
accession to the approved list. It is the case of non–certified suppliers, the
laboratory will have to make its own assessment of their quality assurance
capabilities and/or arrange appropriate checks on supplies on receipt.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Indeed, there is no reason at all why
the Quality Manager cannot take the view that the checks carried out by the
laboratory on receipt of materials or as a part of methods are such that the
supplier’s quality assurance capability is irrelevant. However, if this is the
position, it is still necessary to list the suppliers used and to note that
their use is conditional on the continuation of relevant in–house quality
checks on materials.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Checks on the quality assurance status
of suppliers who provide services such as instrument repairs must also be
considered. Many service agencies and service departments now hold ISO 9001
certification, which simplifies this are considerably. Where there is no
certification, the laboratory will need to carry out its own assessment. As
with the supply of materials, there is rarely a major issue since a laboratory
will generally be able to check an instrument before it is returned to service
after a repair, and normal quality control within methods will provide
additional security. There may, however, be quality issues surrounding response
times to service requests, which will need evaluation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">14.4<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Inspection</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a defined mechanism to
ensure that any goods received are inspected before being released for use.
This should involve a check against the order specification and should pay
particular attention to factors such as specified purity of reagents or
accuracy of calibration of equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An individual should be made responsible
for carrying out the checks, and there should be clear segregation or labelling
of goods to distinguish between those which have been checked and those which
have not yet been released for use.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of services to equipment, an
individual must be given responsibility for deciding on whether the work has
been satisfactory carried out before the serviced equipment is put back in use.
In the case of laboratory instrumentation, this will typically be the duty of
the responsible person.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">14.5<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Administration</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Quality Manager should review the
approved suppliers list at least annually and should review any supplier
immediately if problems become apparent. There must be a general instruction
that any staff member who has problems with the quality of supplies, goods, or
services, must report them to the Quality Manager. This ensures that all the
information comes together at one point. It is not unusual in large
organizations for a supplier to be giving small problems in different
departments which, when brought together, add up to considerable concern about
the supplier’s overall suitability.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A simple strategy for ensuring that the
reports reach the Quality Manager is to instruct that problems with suppliers
are reported to the Quality Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A mechanism should be established to
prevent orders being placed with non–approved suppliers. The usual practice is
to require some person in the order processing chain to verify the order
against the approved supplier list and to endorse it as satisfactory in this
respect. The person charged with this responsibility can be either the person
authorizing the order or an administrator who processes the order. In either
instance, the quality documentation should confirm the person’s authority to
intercept the order.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">14.6<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Starting up the
Approved Supplier List</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A laboratory which is installing a
quality system for the first time will already have several suppliers which are
routinely used. These should all be contacted with an explanation that the
laboratory is seeking accreditation and asked to supply details of their
quality management procedures or certifications.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">If they are unable to do this, the
laboratory need to stop using them, provided that the Quality Manager is
satisfied that the goods or services supplied will be of acceptable quality
and/or adequately checked before use in a situation where the quality of data
is set at risk. A history of use of the supplier with no problems can provide
suitable evidence. In such cases, the Quality Manager should prepare a brief
report on the supplier which details the history of use, and which shows any
supporting evidence for their acceptance. The key point from an assessment
point of view is that the laboratory will have to convince the assessors that
it has information about the supplier’s ability to maintain quality and so can
deal with any local checks needed before goods or services are released for
use.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">14.7<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Operating within
a tendering system</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">One difficulty which sometimes arises is
when laboratories operate in countries where purchases must be via a transparent
tendering system. This often means that the laboratory is not able to select
suppliers nor, in some instances, influence the selection.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The best way to deal with this problem
is to defer evaluation of the supplier until the tendering system is complete.
If the supplier is already on the approved list, then there is no problem. If
the supplier is not approved, the Quality Manager should evaluate whether the
supplier is in compliance with approved supplier status. This means:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo45; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Determine
whether the supplier has certification.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo45; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">If
the supplier has no certifications, then the Quality Manager should determine
what other assurances on quality are available.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l4 level1 lfo45; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">In
the light of the information obtained, the Quality Manager should then decide
on any checks on supplies that need to be made on receipt and before the
supplies are released for use.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The strategy to be adopted then be
recorded and communicated to relevant laboratory staff.</span></span></p><p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;"><br /></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">15.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></b><!--[endif]--><span dir="LTR"></span></span><b><span style="font-family: "Palatino Linotype", serif;"><span style="font-size: medium;">Sub–contracting</span></span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">15.1<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Key Question</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you evaluate the suitability of any subcontractors used against a defined set
of criteria?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a list of these approved subcontractors?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you have a mechanism which ensures that the use of any subcontractors found
unsatisfactory is discontinued?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l32 level2 lfo2; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Courier New"; font-size: 12pt; mso-fareast-font-family: "Courier New";"><span style="mso-list: Ignore;">o<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Do
you obtain clearance from clients before sub–contracting work?</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">15.2<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Requirements</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">ISO 17025 includes the specific
statement that a laboratory is always responsible to the client for the work
the subcontractor performs, although a dispensation is allowed where the client
insists on a particular subcontractor. This is the key requirement, and it
implies that the laboratory investigates and approves its subcontractors, as
described in Section 15.2.1.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The overall need is to satisfy assessors
that subcontractors are selected after careful investigations and that the
laboratory takes a responsible attitude to their selection and continued use.
In practice, accreditation bodies do not apply this requirement with great
rigour and they are reasonably understanding of commercial sensitivities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Sub–contracting should be covered by
contract review as discussed in Section 7.3. This also takes care of the
requirement in the standard to ensure that the client is aware of the
arrangement, although it should be noted that ISO 17025 specifically requires
that the client be informed in writing of the arrangements for sub–contracting.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of reporting back from subcontractors,
a testing laboratory must simply acknowledge that it has been sub–contracted
but calibration laboratories are required to supply the client with the sub–
contractor’s report or certificate. There is no absolute requirement to notify
the client of the identity of the subcontractor although the requirement for
calibration laboratories to pass on the subcontractor’s certificate rather
negates this. Testing laboratories can, however, reserve this information.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">15.2.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Approved
subcontractors</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory must keep a list of
approved subcontractors, normally compiled by the Quality Manager. Laboratories
which operate a quality system in compliance with ISO 17025 are automatically
eligible to appear on this list. They may demonstrate their compliance by
providing evidence of accreditation by an accreditation body constituted in
accordance with ISO 17011.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In the case of non–accredited
laboratories, the Quality Manager will be required to carry out an appraisal,
which might include a visit to the subcontractor to carry out an audit, to
establish to his or her satisfaction, that the laboratory ISO 17025 compliant
in relevant areas. The key issued would be to ensure that the laboratory is
suitably equipped, has training procedures, and records, calibrates its
instruments traceably and has appropriate internal and external quality control
procedures, including participation in relevant interlaboratory proficiency
exercises. A report on the appraisal must be kept on file, and the
authorization should be reviewed at least annually.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A decision should also be made on
whether it is necessary to carry out quality checks on the performance of
subcontractors by, for example, the blind submission of quality control
samples. These checks may be appropriate when initially evaluating the
subcontractor and may also be carried out on an on–going basis. At least
occasional use of such checks is strongly recommended where possible,
especially for non– accredited subcontractors, since it is likely that
assessors will ask the laboratory whether they have any evidence of the quality
of the subcontractor’s work.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Another approach sometimes used is to
arrange for the subcontractor to forward the results of any relevant
interlaboratory proficiency exercises in which they participate. Willingness to
do so, in itself, provides confidence in the subcontractor.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">15.3<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Administration</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a clearly stated policy
on who may authorize sub–contracting. This is normally the Laboratory Manager.
This person should have the responsibility of checking that the subcontractor
is on the approved list and should have the authority to refuse to authorize
the sub–contracting if a non–approved subcontractor is requested.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The Laboratory Manager should review the
performance of subcontractors on a regular basis, and at least annually, and
report any problems to the Quality Manager for investigation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18pt; mso-list: l40 level1 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14pt;">Guidance
on writing a Quality Manual</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.1<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Some general
considerations</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There is no set format for a Quality Manual
and it must, of necessity, be a document individual to the laboratory. It is
the definitive document: it defines the quality management system and the
procedures which implement it.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Accreditation bodies often provide a
guidance document suggesting a format, and there is something to be said for
following their recommendations. Unfortunately, however, this can lead to a
manual which is less than ideal from the laboratory’s point of view and perhaps
has the appearance of being designed by a committee, but it will be relatively
easy for assessors to review, they can check it off against the guidance
document and can hardly object to a manual which follows the document closely.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The contents of the manual and the documents
to which it refers will be the basis for all audits and assessments of the
quality system. It is, therefore, important that the manual describes the
system as it is operated. It must be a working document and not a description
of an ideal world.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Be particularly careful that you cover
all eventualities. If you assign a responsibility to a post holder, remember
that they may not always be available. The manual will need to provide and
alternative, such as a deputy or another point of reference, in these
circumstances. There should be a statement that all responsibilities ultimately
revert to the Laboratory Manager who may delegate them again if necessary. The
Laboratory should always try to ensure that the Laboratory Manager and his or
her deputy are never absent at the same time.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Another important point to remember is
that responsibility and authority go together. Whenever you assign a responsibility,
you must also assign the appropriate authority. In the context of quality
management this may involve giving a Quality Manager authority on quality
matters over a line management superior. The superior, in supporting the
quality policy, should respect this authority.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">You should be careful in writing the
manual not to create procedures and policies which are bound to fail. Within
the limits of the standard, give yourself as much flexibility as possible. You
may describe preferred courses of action but allow alternatives under defined
circumstances if it is clear who has the authority to permit the alternative to
be taken.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For example, a supplier policy may state
that the preferred suppliers would be ISO 9001 certified, but the alternatives
may be used where the goods are not available from such an accredited supplier.
The policy might then go on to state that the Quality Manager may give approval
for the use of an alternative provided that the goods are checked before being
used.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The next section gives one suggested
outline for a Quality Manual that describes an ISO 17025 compliant system, with
some notes on the contents of each section. It is not essential that the
information described appear explicitly in the manual. Subsidiary documentation
can be used and referred to. Be careful, however, not to create an
unnecessarily complex documentation structure as this will be difficult to
maintain. Another trap to avoid is that of duplicating information across
different documents since it is difficult to ensure that the version in the
various documents is all maintained together and remain consistent.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Finally, remember that an assessment
will be against your quality documentation in addition to against the standard.
This means that if you make a commitment in your documentation which goes
beyond the requirements of the standard and then fail to meet it you will still
have non–conformance, even if what you are doing is within the standard.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">For example, ISO 17025 requires an
annual review of the quality system. If you were to enter a commitment to a
six–monthly review in your quality manual but what you do is review annually,
you would be meeting the standard but would still have a non–conformance
against your documentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The rule is not to commit to anything
beyond the standard, even if you intend to go beyond the standard. In the
example given, the quality manual should say that you will review “at least
annually.” This gives you flexibility and conformance with the standard.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36pt; mso-list: l40 level2 lfo1; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2<span style="font: 7pt "Times New Roman";">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">An outline for a
Quality Manual</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.1<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
policy statement and accreditation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This should be made on the authority of
the most senior management body for the laboratory. This must be at the level
where decisions on resource allocation are made. It should contain a commitment
to quality, to good professional practice and to a quality management system
based on ISO 17025. It should also contain a commitment to provide resources to
support this level of quality.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">It is also conventional to include a
commitment to provide only one level of service for tests and calibrations
within the accreditation scope. This requirement arises from a situation where
some laboratories were offering to carry out work either to an accreditation
standard or to a lower standard with a price differential. Accreditation bodies
insist on a single level of service since, otherwise, a laboratory might use its
accreditation to attract the work and then offer an inferior and cheaper
service. It is, however, possible to be accredited for the same test or
calibration to different levels of accuracy, for example, but it is hard to see
any advantage in this in most cases.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The policy statement should carry the
name, position, and signature of an appropriate representative of the senior
management body, ideally the chief executive, and should explicitly give
authority to the Laboratory Manager and the Quality Manager to implement and
operate the quality system. It should also require all personnel to familiarize
themselves with the quality documentation and to always follow its requirements.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The policy statement should be followed
by a reference to any accreditation held by the laboratory and a reference to
an appendix containing the scope of accreditation or the scope which is the
basis of any pending application for accreditation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.2<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Organization
and Management</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should show the internal
organization of the laboratory and the relationship between the laboratory and
any organization of which it is a part. It is a good idea to include
organizational charts. These charts should show that the Quality Manager has
access to the highest level of management and the Laboratory Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Each level of staff should be described,
with an outline of the level of experience and qualifications required to fill
each grade. The object of this is to set a minimum acceptable level of
expertise at each level which the laboratory undertakes to maintain, but the
description should allow sufficient flexibility to admit staff with specialized
but narrow capabilities, where required.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The supervisory requirements at each
grade should be defined, for example an assistant chemist must always work
under the direct supervision of a chemist or higher, and the limits of
responsibility and authority of each grade should be clearly explained.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a statement of the
policy on the use of staff undergoing training and a requirement for their
direct supervision.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Reference should be made to the staff
records or equivalent source as containing a list of current post holders.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.3<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Job
Descriptions</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should contain full job
descriptions of key staff. This must include the Laboratory Manager and the
Quality Manager and their deputies. It should make clear what the
responsibilities of each post are and what functions each performs.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Any other key posts should be included.
Some laboratories, for example, assign duties to a calibration officer who is
responsible for calibrating all instruments and maintaining reference
standards.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.4<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Approved
Signatories</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section must define precisely,
either by name, seniority or post, the individual who are authorized to take
responsibility for the laboratory’s data. Only these individuals may authorize
the release of work and sign test/calibration certificates.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.5<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Acceptance
of work</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should make clear exactly
who may accept work and commit the laboratory to a delivery date. It should
state that the person accepting the work is under an obligation to ensure that
the laboratory has the equipment and expertise to do the work and that they
must not enter a commitment unless they can be certain on this point. The
formal contract review process can be described here.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.6<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Documentation</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The structure of the quality
documentation should be defined. This will normally be a hierarchy, headed by
the quality manual, which refers to the methods manual or equivalent technical
and other procedural documentation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Reference should be made to the
subsidiary records and documentation such as the equipment logs and the staff
records.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The purpose of each piece of
documentation must be defined as well as the person responsible for maintaining
it and authorizing it to be issued. The availability of each document should be
stated, for example whether it is issued and to whom, in whose custody it is
kept, where it is kept and who has right of access.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be an instruction to all
staff to abide by the documented procedures. This should be qualified by
allowing, for example, the Laboratory Manager to permit departures from
documented procedures where technical considerations make this expedient,
provided that he or she is confident that quality will not be undermined as a
result. There must be an instruction that all such departures must be recorded
and noted on reports where relevant.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Staff inadvertently deviating from
documented procedures must be instructed to bring this to the attention of the
Laboratory Manager, who must decide whether quality is compromised and what
action is needed. All such departures must be recorded.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.7<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Document
control</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The controlled document system should be
described and the responsibility and authority of the Quality Manger in this
respect defined.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.8<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Scope
of Tests/Calibrations</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This should state the laboratory’s
policy to use internationally recognized methods wherever possible,
supplemented by fully validated and documented in–house methods. This section
should also include or refer to a list of typical sources for methods appropriate
to the laboratory’s scope of activities.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.9<span style="font: 7pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Test/Calibration
Methods</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a description of the
procedure for introducing a new method. This will generally involve the
Laboratory Manager in arranging to validate and document the method. The
Quality Manager should approve the validation and documentation before the
Laboratory Manger released the method. An outline of the format for in–house
documented methods should be given, and a procedure for the withdrawal or
amendment of a method described.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.10</span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Equipment
and Reference Standards</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should list the major items
of equipment which the laboratory operates, and the reference standards held.
This can be expressed in general terms and reference made to the equipment logs
as a full inventory. The format and operation of the equipment logs should be
described and the procedure for checking and accepting a new piece of equipment
into service, as well as the procedure for the withdrawal of equipment.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.11 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Calibration
Policy</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a statement of the
policy of the laboratory to achieve traceability of all measurements using
traceable (to SI units where relevant) standards of measurement and certified
reference materials. Where there is not achievable there should be a commitment
to interlaboratory calibration exercises and similar measurement audits.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The policy that references are to be
used for calibration only and not for routine purposes should be stated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.12 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Calibration
and Maintenance of Instruments</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a general statement of
the policy to calibrate at intervals such that the integrity of measurements is
not set at risk. The preferred procedures for determining calibration intervals
should be stated. Reference should be made to the procedural documents which
describe instrument calibrations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The procedure of labelling equipment
which requires calibration should be described and instructions not to use
equipment has an expired calibration must be given.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">A general responsibility should be
placed on all staff to ensure that any instrument or piece of equipment which
they suspect is out of calibration is not used until checked. The equipment
must be clearly labelled as suspect and not to be used. The problem should be
brought to the attention of the Laboratory Manager.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.13 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Methods
and uncertainty of measurement</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should describe the
laboratory’s policy and procedures on the determination of method performance
validation and on assessing uncertainty of measurement.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a description of
procedures to be used at initial validation of methods and a description of the
responsibility of the Laboratory Manager for updating the information based on
QC data.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The section should also give guidance on
the general policy of the laboratory on the frequency of running QC samples, spikes,
and duplicates.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.14 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Control</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a general statement on
which level of staff or individuals are permitted to judge whether results meet
quality control criteria. Reference should be made to the fact that methods
documentation includes details of the quality control data to be collected and
the criteria to be applied.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The general responsibility of the
Laboratory Manger to monitor and act upon quality control data should be
stated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be a commitment to
interlaboratory proficiency checking exercises and/or measurement audit and a
list of such exercises in which the laboratory typically participates.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.15 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedure
when data is suspect.</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The procedure to be followed when a
suspicion that faulty data has been released should be described. This will
normally require investigation by the Laboratory Manager and Quality Manager
and probably an audit. Corrective action would also normally be required. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory’s policy to inform
clients as soon as possible of suspect data must be stated with a commitment to
check the data and, if necessary, to issue an amended report.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.16 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Handling
of samples and administration of work</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should have a complete
description of the laboratory’s procedure for receiving, storing, and recording
samples, sample numbering and labelling, allocation of work, recording of
results, quality checking of results, preparation of reports and issuing
reports.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">In writing this section try to describe
in a systematic way the manager in which samples and results are managed
through your laboratory. Pay particular attention to how the clients’ requirements
are communicated to the bench workers and how the bench workers pass the
results back the reporting process.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.17 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Recording
of Results</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should describe the use of
worksheets and/or notebooks. Instructions on the use of ink and the way of making
corrections should be given.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.18 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Disposal
of samples and other waste</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory’s policy on the length of
time samples is kept should be stated, as should the policy on disposal, with a
commitment to the responsible disposal of toxic materials.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.19 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Records</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory policy on the retention
of records should be stated and the procedure be followed in disposal of
records must be given. This should define who may authorize disposal and
require that an inventory be kept of the records disposed of.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The policy on security of records,
including computer data, must be stated, and the person responsible for
archiving and computer back– up identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.20 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Reporting
of Results</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The minimum requirement for the contents
of a report should be given (see Section 13.2) and an example of the preferred
layout included.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The requirement to identify
sub–contracted results must be stated. Where the laboratory holds accreditation
there must also be a stated procedure for identifying results of methods not
included in the accreditation scope.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The procedure for retaining
confidentiality when reporting results other than by post should be set out.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where reports have to be amended there
must be a statement that this can only be done by the issue of a complete new
version with an endorsement such as “Amendment to Certificate No. …..”</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.21 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Quality
Incidents, Complaints and Control of Non–conforming Work</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory’s policy to treat
complaints positively and as a source of useful information should be stated.
The persons authorized to deal with complaints should be identified and the
procedure for recording complaints and following them up defined, including the
requirements for corrective action.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The system for dealing with internally
detected quality problems and incidences of non–conforming work need to be
clearly described. This should include assignment of responsibility for
ensuring work is suspended pending an investigation and the carrying out of
corrective action. The person responsible for allowing work to be resumed needs
to be identified.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.22 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Confidentiality</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory’s policy to retain
confidentiality should be stated. Instructions must be included that all staff
must take all reasonable precautions to keep client’s data and other
information confidential. The requirement to ensure that no such information is
left out in the laboratory overnight or in an unattended room should be stated.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.23 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Staff
appointment, training, and review</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The operation of the staff records must
be described including their use for recording new staff and changed in the
training or status of existing staff.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The mechanism for selecting staff for
training, carrying out the training and assessing competence and for issuing
authorization to carry out tests, calibrations and other procedures should be
described.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The mechanism for an annual review of
staff capabilities must be laid out and the means of recording the results.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Staff should be generally instructed of
their responsibility to carry out only operations for which they are
authorized. It should be made clear that staff are entitled to refuse to do
work for which they are not authorized.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.24 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Procedures
for audit and review of the Quality System</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">All the procedures for the audit and
review of the quality system should be described together with the records to
be kept, and the policy on frequency of audits and review included.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.25 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Corrective
action</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The procedure for agreeing and recording
corrective action should be described, as well as a description of the
procedure for follow up to ensure corrective action is complete and has been
effective.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.26 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Preventive
action and Improvement</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The procedure for identifying preventive
action and quality improvement opportunities should be described, and the
responsibility for evaluating suggestions and carrying out the preventive
action assigned.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.27 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Premises
and Environment</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">The laboratory premises should be
described and, ideally, a plan included. This section should also draw
attention to any parts of the premises to which access is restricted and who is
authorized to grant access and should describe any areas subject to special
environmental controls as well as the mechanism for monitoring, recording and
maintaining such control.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">Where laboratories conduct activities
which are incompatible, for example trace and high-level analysis for metals,
there should be a description of the facilities provided to ensure the
necessary segregation.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.28 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Security
of Premises</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">This section should describe the
arrangements for the security of the premises during and outside working hours,
identify the persons authorized to hold keys, describe the procedure for
granting authorization, and identify the person with overall responsibility for
security.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt; mso-list: l40 level3 lfo1; text-indent: -36pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">16.2.29 </span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Appendices</span></b></span></p>
<p class="MsoNoSpacing" style="margin-left: 72pt;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">There should be appendices covering, as
a minimum, the following topics:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l25 level1 lfo47; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
list of the scope of accreditation held or applied for.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l25 level1 lfo47; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
list of holders of the quality manual.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l25 level1 lfo47; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">A
list of all controlled documents and subsidiary documentation together with
their scope of issue or storage locations.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l25 level1 lfo47; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;">Examples
of pro–formas for recording quality issues such as audits, corrective and
preventive action and client complaints.</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 90pt; mso-list: l25 level1 lfo47; text-indent: -18pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span></span><span style="font-family: "Palatino Linotype",serif; font-size: 12pt;"><span style="color: #01ffff;">An
example of the laboratory’s proposed report format. </span><o:p></o:p></span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-80996471781982145762023-03-01T19:24:00.000+08:002023-03-01T19:24:16.209+08:00ISO 17025 Self Assessment Compliance<p><span style="color: #01ffff;"> </span></p><p></p><div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="7" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 16.0pt;">SELF–EXAMINATION
QUESTIONNAIRE </span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 16.0pt;">FOR ISO 17025
COMPLIANCE</span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">MEASURABLE
ELEMENTS<o:p></o:p></span></span></b></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">4<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">ORGANIZATION</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
the laboratory managed in such a way that it operates independently and is
free from external influences?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">MANAGEMENT
REQUIREMENTS</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
Senior Management committed to quality system, including compliance with ISO
17025, and agreed that resources will be provided to establish and maintain
it?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
staff at all levels recognize that, irrespective of workload and other
pressures, the requirements of the quality system must be followed at all
times?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
there a person who is responsible for establishing and monitoring compliance
with the quality system on a day-to-day basis?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
there a documented specification of the quality management system, for
example in a quality manual, with clear assignment of authority and
responsibility such that the managers who supervise work have authority to ensure
the quality of the work which they supervise? <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">DOCUMENT CONTROL</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
there documents available that give work instructions so that staff have a source
of reference to enable them to conduct their work properly and consistently? <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
all documents controlled? Which means can you answer “yes” to the following:<o:p></o:p></span></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
all documents giving instructions or used to record data authorized by
defined management personnel?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
a record of the issue of all documents kept and procedures adopted so that
when amendments are made, every copy can be retrieved to be updated?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">SUBCONTRACTING
OF TEST </span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">AND
CALIBRATIONS</span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have a list of approved subcontractors?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have a record of the accreditations of the subcontractors?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Where
subcontractors are not accredited do you have other evidence that they are
competent?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">PURCHASING SERVICES
AND SUPPLIES</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have a list of approved suppliers and a policy for inclusion of a
supplier on the list?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Does
this policy ensure that purchased materials and services will be good enough
to ensure that the quality of your data is not threatened?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">SERVICE TO CLIENTS
AND COMPLAINTS</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
clients know how to contact you and who to speak to about the progress of
their work?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you follow up complaints from clients and learn from them so that you can
take steps to ensure that the problem does not happen again?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">CONTROL OF NON–CONFORMING
WORK</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Nonconforming
work occurs when data or services are detected which do not meet the
laboratory’s agreed standard of quality. This may be detected internally or
externally. <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have a procedure for ensuring that work or release of data, is stopped
immediately nonconforming work is identified?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you follow up on nonconforming work in order to learn from it and take action
to ensure that the problem cannot happen again?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">CORRECTIVE
ACTION</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Where
quality problems are identified, do you have a procedure for ensuring that
prompt corrective action is taken?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you ensure that the corrective action taken addresses the root cause of the
problem, i.e., do you think that you normally make it unlikely that the problem
will happen again?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you follow up to ensure that the corrective action has been effective, for
example after a period of settling in?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 32;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">PREVENTIVE
ACTION</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 33;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you track trends so that you can respond to deterioration in quality before
it reaches unacceptable levels?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 34;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you hold regular meetings of senior technical staff to discuss areas of concern
about quality and consider proposals for improvement?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 35;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you track measurable items, for example turnaround times, numbers of re–tests
necessary, and respond when performance appears to be deteriorating?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 36;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">RECORDS</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 37;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Where
documentation requires a procedure to be followed do you have records which
show whether it was actually done or not?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 38;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Would
your records enable you to identify the person who did each piece of work?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 39;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Would
your records enable you to identify the equipment used? <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 40;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Would
your records enable you to prove that the equipment was properly calibrated
and functioning correctly?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 41;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;"><span style="color: #01ffff;">INTERNAL
AUDITS AND <o:p></o:p></span></span></b></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">MANAGEMENT REVIEWS</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 42;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you carry out record regular inspections to check that the procedures which
you have defined and documented are, in fact, being followed?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 43;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Does
senior management carry out reviews to determine whether the quality system continues
to meet the needs of the organization?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 44;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">PERSONNEL</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 45;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have appropriate numbers and types of staff so that work can be carried
out without having to rush so much that quality may be compromised?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 46;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you formally check if all persons performing technical functions possess the
required educational/professional qualifications and experience?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 47;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
there clearly defined descriptions set out for each of the persons working in
the laboratory?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 48;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have a procedure for regular performance evaluation to assess their
competence?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 49;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have a procedure for training staff in testing and/or calibration?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 50;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">ACCOMODATION
AND ENVIRONMENT CONDITIONS</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 51;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Does
the accommodation provide adequate separation of functions to minimize the possibility
of cross contamination? (Give a lab floor plan?)<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 52;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
you confident that the conditions and standard of housekeeping in your laboratory
are adequate to ensure that the quality of data is not being compromised?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 53;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
there measure to provide uninterrupted services (electricity, gas, water)?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 54;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
there measures to restrict the entry of unwanted materials and persons into
the laboratory? <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 55;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
there appropriate storage facilities to provide integrity of samples before
and after testing?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 56;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">TEST AND
CALIBRATION METHODS, VALIDATION AND QUALITY CONTROL</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 57;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you use only standard, internationally accepted methods for testing?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 58;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
all methods documented to the extent necessary to enable them to be performed
properly and consistently?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 59;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have validation data which shows the performance characteristics, for
example accuracy and precision, of all the methods which you carry out?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 60;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
quality control procedures in place to ensure that the performance
characteristics established for the methods continue to be met on a routine
basis?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 61;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
the laboratory staff trained in sampling?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 62;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Where
these are available, does the laboratory make regular measurements on
certified reference materials to confirm the accuracy of its measurements?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 63;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Where
available, does the laboratory participate in interlaboratory comparison exercises,
i.e., exchange of samples with other laboratories and comparison of results?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 64;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;"><span style="color: #01ffff;">CONTROL OF
DATA AND</span></span></b></p><p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;"><span style="color: #01ffff;">DATA INTEGRITY</span></span></b></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 65;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
all raw data recorded at the time of observation and traceable, for examples
by being signed, to the person who made the observation?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 66;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
transfers of data between documents, or between documents and computers,
subject to checks?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 67;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">EQUIPMENT,
CALIBRATION </span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">AND
TRACEABILITY</span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 68;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
operational procedure charts available with each of the equipment?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 69;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Where
the concept is applicable, has equipment been calibrated to ensure
traceability to the SI system of unit through an unbroken and, if necessary,
international chain?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 70;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Are
regular cleaning and maintenance checks performed?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 71;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have evidence to show that calibration is carried out often to ensure
that drift between calibrations is not so large as to undermine data quality?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 72;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Where
practicable, is equipment checked between calibration and records kept to
confirm that it has not drifted and lost its calibration?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 73;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
all equipment which is subject to regular checks or calibrations labelled to
show when the next calibration or check is due?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 74;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Is
there a record of all equipment and particularly of its cleaning, maintenance
and calibration history?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 75;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">HANDLING OF
TEST </span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">AND
CALIBRATION OF ITEMS</span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 76;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have a system for uniquely labelling and numbering items so that the number
remains with all samples and sub–samples as the item moves through the laboratory?<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 77;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Do
you have procedures for identifying samples which requires special storage or
preservation and for ensuring that appropriate action is taken? <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 78;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">REPORTING</span></b><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p></o:p></span></b></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 79;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">The
basic required contents of a report are as follows: <o:p></o:p></span></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="background: #BFBFBF; border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 80;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Name
and address of the laboratory <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 81;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Name
and address of client<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 82;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Unique
identifier of certificate or report (such as serial number);<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 83;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">On
each sheet of the certificate or report, a unique form of sheet identifier
(such as the serial number of the certificate or report, with a unique page
number in the form “page – of – pages”<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 84;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Date
of receipt of calibration or test item, and date(s) of performance
calibration or test, as appropriate; <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 85;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Date
of issue of certificate or report; <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 86;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Signature
and legible name of approved signatory or signatories taking responsibility for
the content of the certificate or report, or equivalent form of technical
authorization; <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 87;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">h.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Unambiguous
identification of item(s) calibrated or tested (including name of manufacturer
of item(s), any model or type designation and any relevant serial numbers, as
appropriate); <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 88;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">i.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Any
abnormalities or departures from standard conditions; <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 89;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">j.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Reference
to calibration or test method and procedure used; <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 90;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">k.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Any
standard or other specification relevant to the calibration or test method or
procedure, and deviations, additions to or exclusions from the specification concerned;
<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 91;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">l.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Where
relevant to the validity or application of the calibration or test result(s),
details of any sampling, item preparation, or data analysis; <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 92;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">m.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Calibration
or test result(s); <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 93;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">n.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Any
design or performance specifications met or failed; <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 94;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">o.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Estimated
uncertainty of the calibration or test result (this information need only
appear in test reports and test certificates where it is relevant to the validity
or application of the test result, where a client’s instructions so require,
or where uncertainty affects compliance to a specification or limit);<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 95;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">p.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Any
other available information requested by a client relevant to the validity or
applicability of the calibration or test result. <o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 96;">
<td colspan="7" style="background: #BFBFBF; border-top: none; border: solid windowtext 1.0pt; mso-background-themecolor: background1; mso-background-themeshade: 191; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 4.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 97;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 311.6pt;" valign="top" width="415">
<p align="right" class="MsoNoSpacing" style="text-align: right;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">Total Score<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 35.45pt;" valign="top" width="47">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 32.85pt;" valign="top" width="44">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 98;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 99.0pt;" width="132">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">SCORING<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">SYTEM<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 42.5pt;" width="57">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">1<o:p></o:p></span></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 309.3pt;" valign="top" width="412">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">No,
we <b>do not</b> meet this requirement at all<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 99;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 42.5pt;" width="57">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">2<o:p></o:p></span></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 309.3pt;" valign="top" width="412">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">We
meet <b>some</b> parts of this requirements<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 100;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 42.5pt;" width="57">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">3<o:p></o:p></span></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 309.3pt;" valign="top" width="412">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">We
meet <b>most</b> parts of this requirements<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 101; mso-yfti-lastrow: yes;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 42.5pt;" width="57">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">4<o:p></o:p></span></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 309.3pt;" valign="top" width="412">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;"><span style="color: #01ffff;">We
meet these requirements <b>fully</b><o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div><br /><p></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-23392812858906320702023-02-20T21:44:00.001+08:002023-03-01T19:27:34.841+08:00Statistical Method for Proficiency Testing<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-table-layout-alt: fixed; mso-yfti-tbllook: 1184; width: 601px;">
<tbody><tr>
<td colspan="4" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 451.1pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">STATISTICAL
METHOD FOR PROFICIENCY TESTING<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">GENERAL<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
Test results can appear in many forms,
spanning a wide range of data types and underlying statistical distributions.
The statistical methods used to analyse the results needs to be appropriate
for each situation, and so are too varied to be specified in this
International Standard. ISO 13528 describes preferred specific methods for
each of the situations discussed below, but also states that other methods
may be used as along as they are statistically valid and are fully described
to participants. Some of the methods in ISO 13528, especially for homogeneity
and stability testing, are modified slightly in the IUPAC<sub>2</sub>)
Technical Report “The International Harmonized Protocol for the Proficiency
Testing of Analytical Chemistry Laboratories.” These documents also present
guidance on design and visual data analysis. Other references may be
consulted for specific types of Proficiency Testing Schemes, e.g. measurement
comparison schemes for calibration. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
methods discussed in this annex and in the reference documents cover the
fundamental steps common to nearly all Proficiency Testing Schemes, i.e.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Determination
of the assigned value, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Calculation
of performance statistics,<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Evaluation
of performance, and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Preliminary
determination of Proficiency Test item homogeneity and stability<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">With
new Proficiency Testing schemes, initial agreement between results is often
poor, due to new questions, new forms, artificial test items, poor agreement
of test or measurement methods, or variable measurement procedures.
Coordinators may have to use robust indicators of relative performance (such
as percentiles) until agreement improves. Statistical methods may need to be
refined once participant agreement has improved and Proficiency Testing is
well established. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
annex does not consider statistical methods for analytical studies other than
for treatment of Proficiency Test data. Different methods may be needed to
implement the other uses of interlaboratory comparison data listed in the
introduction. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">DETERMINATION
OF THE ASSIGNED VALUE AND ITS UNCERTAINTY<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="17" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.2.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">There
are various procedures available for the establishment of assigned values.
The Most common procedures are listed below in an order that, in most cases,
will result in increasing uncertainty for the assigned value. These
procedures involve the use of: <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Known
values</span></b><span style="font-family: "Palatino Linotype", serif;">
– with results determined by specific Proficiency Test item formulation (e.g.
manufacture or dilution) <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Certified
reference values</span></b><span style="font-family: "Palatino Linotype", serif;">
– as determined by definitive test or measurement methods (for quantitative
tests); <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Reference
values</span></b><span style="font-family: "Palatino Linotype", serif;">
– as determined by analysis, measurement or comparison of the Proficiency
Test item alongside a reference material or standard, traceable to a national
or international standard; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Consensus
values from expert participants</span></b><span style="font-family: "Palatino Linotype", serif;"> – experts (which may, in some
situations, be reference laboratories) should have demonstrable competence in
the determination of the measurements under test, using validated methods
known to be highly accurate and comparable to methods in general use; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo2; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Consensus
values from participants</span></b><span style="font-family: "Palatino Linotype", serif;"> – using statistical methods described in ISO
13528 and the IUPAC International Harmonized Protocol and with consideration
of the effect of outliers. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.2.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Assigned
values should be determined to evaluate participants fairly, yet to encourage
agreement among test or measurement methods. This is accomplished through
selection of common comparison groups and the use of common assigned values,
wherever possible. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.2.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Procedures
for determining the uncertainty of assigned values are discussed in detail in
ISO 13528 and the IUPAC International Harmonized Protocol, for each common
statistic used (as mentioned above). Additional information on uncertainty is
also provided in ISO/IEC Guide 98–3. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.2.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Statistical
methods for determining the assigned value for qualitative data (also called
“categorical” or “nominal” values), or semi–quantitative values (also called
“ordinal” values) are not discussed in ISO 13528 or the IUPAC International
Harmonized Protocol. In general, these assigned values need to be determined
by expert judgement or manufacture. In some cases, a proficiency testing
provider may use a consensus value, as defined by agreement of a
predetermined majority percentage of responses (e.g. 80% or more). However,
the percentage used should be determined based on objectives for the
Proficiency Testing Scheme and the level of competence and experience of the
participants. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.2.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Outliers
are statistically treated as described below,<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Obvious
blunders, such as those with incorrect units, decimal point errors, and the
result for a different Proficiency test item should be removed from the data
set and treated separately. These results should not be subject to outlier
tests or robust statistical methods. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">When
participants’ results are used to determine assigned values, statistical
methods should be in place to minimize the influence of outliers. This can be
accomplished with robust statistical methods or by removing outliers prior to
calculation. In larger or routine Proficiency Testing schemes, it may be
possible to have automated outlier screens, if justified by objective
evidence of effectiveness. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">If
results are removed as outliers, they should be removed only by calculations
of summary statistics. These results should still be evaluated within the
Proficiency Testing scheme and be given the appropriate performance
evaluation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">ISO
13528 describes a specific robust method for determination of the consensus
mean and standard deviation, without the need for outlier removal. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.2.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Other
considerations are outlined below,<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Ideally,
if assigned values are determined by participant consensus, the Proficiency
Testing provider should have a procedure to establish the trueness of the
assigned values and for reviewing the distribution of the data. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
proficiency testing provider should have criteria for the acceptability of an
assigned value in terms of its uncertainty. In ISO 13528 and in the IUPAC
International Harmonized Protocol, criteria are provided that are based on a
goal to limit the effect that uncertainty in the assigned value has on the
evaluation, i.e. the criteria limit the probability of having a participant
receive an unacceptable evaluation because of uncertainty in the assigned
value. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">CALCULATION
OF PERFORMANCE STATISTICS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="27" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Performance
for Quantitative Results<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="17" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
Test results often need to be transformed into a performance statistic, in
order to aid interpretation and to allow comparison with defined objectives.
The purpose is to measure the deviation from the assigned value in a manner
that allows comparison with performance criteria. Statistical methods may
range from no processing required to complex statistical transformations. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Performance
statistics should be meaningful to participants. Therefore, statistics should
be appropriate for the relevant tests and be well understood or traditional
within a particular field. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
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<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.1.3<o:p></o:p></span></span></p>
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<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Commonly
used statistics for quantitative results are listed below, in order of
increasing degree of transformation of participant’s results. <o:p></o:p></span></span></p>
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<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
difference, D, is calculated using Equation (B.1): <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">D = (x – X) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">where<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">x – is the participant’s result; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">X – is the assigned value<o:p></o:p></span></span></p>
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<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
percent difference, <i>D<sub>%</sub></i>, is calculated using equation (B.2):
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="color: #01ffff; font-size: medium;"><i><span style="font-family: "Palatino Linotype", serif;">D<sub>%</sub></span></i><span style="font-family: "Palatino Linotype", serif;"> = <u>(x – X)</u>
x 100<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> X<o:p></o:p></span></span></p>
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<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
z scores are calculated using Equation (B.3)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">z = <u>x – X</u><o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"> </span><span style="font-family: Arial, sans-serif;">δ<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">where </span><span style="font-family: Arial, sans-serif;">δ </span><span style="font-family: "Palatino Linotype", serif;">is the standard deviation for Proficiency Assessment, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">a fitness for purpose goal for
performance, as determined by expert judgement or regulatory mandate
(prescribed value); <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">an estimate from previous
rounds of Proficiency Testing or expectations based on experience (by
perception); <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">an estimate from a statistical
model (general model); <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">the results of a precision
experiment; or<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">participant results, i.e. a
traditional or robust standard deviation based on participant results. <o:p></o:p></span></span></p>
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<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
zeta score, </span><span style="font-family: Arial, sans-serif;">ζ</span><span style="font-family: "Palatino Linotype", serif;">, is
calculated using Equation (B.4), where calculation is very similar to the <i>E<sub>n</sub></i>
number (see e) below, except that standard uncertainties are used rather than
expanded uncertainties. This allows the same interpretation as for
traditional z scores.<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><span style="font-family: Arial, sans-serif;">ζ</span><span style="font-family: "Palatino Linotype", serif;"> = <u> x – X____ </u> <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> √ <i><sup>u</sup>lab<sup>2</sup></i> + <i><sup>u</sup>av<sup>2<o:p></o:p></sup></i></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><i><sup><span style="font-family: "Palatino Linotype", serif;">u</span></sup></i><i><span style="font-family: "Palatino Linotype", serif;">lab<sup>2</sup></span></i><span style="font-family: "Palatino Linotype", serif;"> is
the combined standard uncertainty of a participant’s result;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><i><sup><span style="font-family: "Palatino Linotype", serif;">u</span></sup></i><i><span style="font-family: "Palatino Linotype", serif;">av<sup>2</sup> </span></i><span style="font-family: "Palatino Linotype", serif;">is
the standard uncertainty of the assigned value<o:p></o:p></span></span></p>
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<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><i><span style="font-family: "Palatino Linotype", serif;">E<sub>n</sub></span></i><span style="font-family: "Palatino Linotype", serif;"> numbers are calculated using Equation (B.5)<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><i><span style="font-family: "Palatino Linotype", serif;">E<sub>n</sub></span></i><span style="font-family: "Palatino Linotype", serif;"> = <u> x – X____ </u> <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> √ <i>U<sub>lab</sub><sup>2</sup></i>
+ <i>U<sub>ref</sub><sup>2</sup></i><o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><i><span style="font-family: "Palatino Linotype", serif;">U<sub>lab</sub></span></i><span style="font-family: "Palatino Linotype", serif;"> is the expanded uncertainty of a participant’s result; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="color: #01ffff; font-size: medium;"><i><span style="font-family: "Palatino Linotype", serif;">U<sub>ref</sub></span></i><span style="font-family: "Palatino Linotype", serif;"> is the expanded uncertainty of the reference laboratory’s assigned
value</span><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></span></p>
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<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 1<o:p></o:p></span></span></p>
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<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
formula in Equations (B.4) and (B.5) are correct only x and X are
independent.<o:p></o:p></span></span></p>
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<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 2<o:p></o:p></span></span></p>
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<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For
additional statistical approaches, see ISO 13528 and the IUPAC International
Harmonized Protocol.<o:p></o:p></span></span></p>
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<tr>
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.1.4<o:p></o:p></span></span></p>
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<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
aspects below should be taken into consideration, <o:p></o:p></span></span></p>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
simple difference between the participant’s result and the assigned value may
be adequate to determine performance, and is most easily understood by
participants. The quantity (x – X) is called “estimate of laboratory bias” in
ISO 5725–4 and ISO 13528. <o:p></o:p></span></span></p>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
percent difference is independent of the magnitude of the assigned value and
is well understood by participants. <o:p></o:p></span></span></p>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Percentiles
or ranks are useful for highly disperse or skewed results, ordinal responses,
or when there are a limited number of different responses. This method should
be used with caution. <o:p></o:p></span></span></p>
</td>
</tr>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Transformed
results may be preferred, or necessary, depending on the nature of the test.
For example, dilution–based results are a form of geometric scale,
transformable by logarithms. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">If
consensus is used to determine </span><span style="font-family: Arial, sans-serif;">δ</span><span style="font-family: "Palatino Linotype", serif;">, the estimate of variability should
be reliable, i.e. based on enough observations to reduce influence of
outliers and achieve sufficiently low uncertainty.<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">If
scores consider the participant’s reported estimates of measurement
uncertainty (e.g. with <i>E<sub>n</sub></i></span><span style="font-family: "Palatino Linotype", serif;"> </span><span style="font-family: "Palatino Linotype", serif;">scores or zeta
scores), these will only be meaningful if the uncertainty estimates are
determined in a consistent manner by all participants, such as in accordance
with the principles in ISO/IEC Guide 98 – 3. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Performance
for Qualitative and Semi–quantitative Results<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For
qualitative or semi–quantitative results, if statistical methods are used,
they must be appropriate for the nature of the responses. For qualitative
data (also called “categorical” data), the appropriate technique is to
compare a participant’s result with the assigned value. If they are
identical, then performance is acceptable. If they are not identical, then
expert judgement is needed to determine if the result is fit for its intended
use. In some situations, the proficiency testing provider may review the
results from participants and determine that a proficiency testing item was
not suitable for evaluation, or that the assigned value was not correct.
These determinations should be part of the plan for the scheme and understood
by the participants in advance of the operation of the scheme.<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For
semi–quantitative results (also called “ordinal” results), the techniques
used for qualitative data (B.3.2.1) are appropriate. Ordinal results include,
for example, responses such as grades or rankings, sensory evaluations, or
strength of a chemical reaction (e.g. 1+, 2+, 3+, etc.). Sometimes these
responses are given as numbers, e.g. 1 = Poor, 2 = Unsatisfactory, 3 =
Satisfactory, 4 = Good, 5 = Very Good. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
is not appropriate to calculate usual summary statistics for ordinal data,
even if the results are numerical. This is because the numbers are not on an
interval scale, i.e., the difference between 1 and 2, in some objective
sense, may not be the same as the difference between 3 and 4, so averages and
standard deviations cannot be interpreted. Therefore, it is not appropriate
to use evaluation statistics such as z scores for semi–quantitative results.
Specific statistics, such as rank or order statistics, designed for ordinal
data, should be used. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.2.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
is appropriate to list the distribution of results from all participants (or
produce a graph), along with the number or percentage or results in each
category, and to provide summary measures, such as the modes (most common
responses) and range (lowest and highest response). It may also be
appropriate to evaluate results as acceptable based on closeness to the
assigned value, e.g. results within plus or minus one response from the
assigned value may be fit for the purpose of the measurement. In some
situations, it may be appropriate to evaluate performance based on
percentiles, e.g. the 5% of results farthest from the mode or farthest from
the assigned value may be determined to be unacceptable. This should be based
on the Proficiency Testing scheme plan (i.e. fitness for purpose) and
understood by participants in advance. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.3.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Combined
Performance Scores<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Performance
may be evaluated on the basis of more than one result in a single Proficiency
Testing round. This occurs when there is more than one Proficiency Test item
for a particular measurement, or a family of related measurements. This would
be done to provide a more comprehensive evaluation of performance. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Graphical
methods, such as the Youden Plot or a plot showing Mandel’s <i>h</i>–statistics,
are effective tools for interpreting performance (ISO 13528).<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
general, averaged performance scores are discouraged because they can mask
poor performance on one or more Proficiency Test items that should be
investigated. The most commonly combined performance score is simply the
number (or percentage) of results determined to be acceptable. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">EVALUATION
OF PERFORMANCE<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Initial
Performance<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="10" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Criteria
for Performance Evaluation should be established after taking into account
whether the performance measure involves certain features. The features for
performance evaluation are the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Expert
consensus, where the advisory group, or other qualified experts, directly
determine whether reported results are fit for their intended purposes;
agreement of experts is the typical way to assess results for qualitative
tests; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Fitness
for purpose, predetermined criteria that consider, for example, method
performance specifications and participant’s recognized level of operation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Statistical
determination for scores, i.e. where criteria be appropriate for each score;
common examples of application of scores are as follows: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l9 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">1.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">For
z scores and zeta scores (for simplicity, only “z” is indicated in the
examples below, but “</span><span style="font-family: Arial, sans-serif;">ζ</span><span style="font-family: "Palatino Linotype", serif;">” may be
substituted for “z” in each case):<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">|z|≤ 2,0 – indicates
“satisfactory” performance and generates no signal;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">2,0 <|z|< 3,0 – indicates
“questionable performance and generates a warning signal;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">|z|≥ 3,0 – indicates
“unsatisfactory” performance and generates an action signal;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l9 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">2.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">For
<i>E<sub>n</sub></i> numbers<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">|<i>E<sub>n</sub></i>|≤ 1,0 –
indicates “satisfactory” performance and generates no signal; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 53.45pt; mso-list: l4 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">-<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">|<i>E<sub>n</sub></i>|> 1,0
– indicates “unsatisfactory” performance and generates an action signal. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For
split–sample designs, an objective may be to identify in results inadequate
calibration or large random fluctuation, or both. In these cases, evaluations
should be based on an adequate number of results and across a wide range of
concentrations. Graphical presentations are useful for identifying and
describing these problems, and are designed in ISO 13528. These graphs should
use differences between results on the vertical axis, rather than plots of
results from one participant versus another, because of problems of scale.
One key consideration is whether results from one of the participants have,
or can be expected to have, lower measurement uncertainty. In this case,
those results, are the best estimate of the actual level of measurement. If
both participants have approximately the same measurement uncertainty, the
average of the pair of results is the preferred estimate of actual level. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.1.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Graphs
should be used whenever possible to show performance (e.g. histograms, error
bar charts, ordered z score charts), as described in ISO 13528 and the IUPAC
International Harmonized Protocol. These charts can be used to show: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Distribution
of participant values; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Relationship
between results on multiple Proficiency Test items;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Comparative
distributions for different methods<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Monitoring
Performance over time<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A
Proficiency Test scheme can include procedures to monitor performance over
time. The procedures should allow participants to see the variability in
their performance, whether there are general trends or inconsistencies, and
where the performance varies randomly. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Graphical
methods should be used to facilitate interpretation by a wider variety of
readers. Traditional “Shewhart” control charts are useful, particularly for
self – improvement purposes. Data listings and summary statistics allow more
detailed review. Standardized performance scores used to evaluate
performance, such as the z score, should be used for these graphs and tables.
ISO 13528 presents additional examples and graphical tools. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.4.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
a consensus standard deviation is used as the standard deviation for
Proficiency Testing, caution should be taken when monitoring performance over
time, as the participant group can change, and can have unknown effects on
the scores. It is also common for the interlaboratory standard deviation to
decrease over time, as participants become familiar with the Proficiency
Testing scheme or as methodology improves. This could cause an apparent
increase in z scores, when a participant’s individual performance has not
changed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.5<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">DEMONSTRATION
OF PROFICIENCY TEST ITEM HOMOGENEITY AND STABILITY<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.5.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
requirements of this International Standard call for a demonstration of
“sufficient homogeneity” with valid statistical methods, including a
statistically random selection of a representative number of samples.
Procedures for this are detailed in ISO 13528 and the IUPAC International
Harmonized Protocol. These documents define “sufficient homogeneity” relative
to the evaluation interval for the Proficiency Testing scheme, and so the
recommendations are based on allowances for uncertainty due to inhomogeneity
relative to the evaluation interval. While ISO 13528 places a strict limit on
inhomogeneity and instability to limit the effect on uncertainty and
therefore the effect it has on the evaluation, the IUPAC International
Harmonized Protocol expands the criteria to allow a statistical test of the
estimate of inhomogeneity and instability, relative to the same criterion
recommended in ISO 13528.<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.5.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">There
are different needs for requirements in ISO Guide 34 and ISO Guide 35, which
are for determining reference values for certified reference materials,
including their uncertainties. ISO Guide 35 uses statistical analysis of
variance to estimate the “bottle–to–bottle” variability and “within–bottle”
variability (as appropriate), and subsequently uses those variances as
components of the uncertainty of the assigned value. Given the need to
estimate components accurately for certified reference materials, the number
of randomly selected samples may exceed what is needed for Proficiency
Testing, where the main objective is to check for unexpected inconsistencies
in batches of manufactured proficiency test items. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">B.5.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Stability
is normally checked to ensure that the measurements did not change during the
course of the round. A specified in ISO 13528, the IUPAC International
Harmonized Protocol and ISO Guide 35, proficiency test items should be tested
under the variety of conditions that occur in the normal operation of a
proficiency testing scheme, e.g. conditions of shipping and handling when
distributed to participants. The criterion for acceptable instability is the
same as the criterion for inhomogeneity in ISO 13528, although typically with
fewer tests or measurements. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 451.1pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">SELECTION AND
USE OF PROFICIENCY TESTING</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">GENERAL<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
annex establishes principles for the selection and use of Proficiency Testing
schemes by participants and other interested parties. This annex is also
intended to promote the harmonized use of Proficiency Testing schemes by
interested parties (e.g. accreditation bodies, regulatory bodies, or
customers of the participant). Since results from Proficiency Testing schemes
may be used in the evaluation of a participant’s performance, it is important
that both the interested parties and participants have confidence in the
development and operation of the Proficiency Testing schemes. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
is also important for participants to have a clear understanding of the
policies of the interested parties for participation in such Proficiency
Testing schemes, and their policies and procedures for following up any
unsatisfactory results from a proficiency test round. However, apart from
specific requirements from regulatory bodies, it is the responsibility of the
participants themselves to select the appropriate proficiency testing scheme
and to evaluate their results correctly. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
should be recognized, however, that interested parties also take into account
the suitability of test data produced from activities other than Proficiency
Testing schemes, including, for example, results of participant’s own
internal quality control procedure with control samples, comparison with
split–made data from other participants and performance on tests of certified
reference materials. Therefore, when selecting a Proficiency Testing scheme,
the participant should take into consideration the other quality control
activities that are available or have already been performed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">SELECTION
OF PROFICIENCY TESTING SCHEMES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="14" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.2.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Laboratories
(and other types of participants) need to select Proficiency Testing schemes
that are appropriate for their scope of testing or scope of calibration. The
Proficiency Testing schemes selected should comply with the requirements of
this International Standard. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td rowspan="12" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.2.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
selecting a Proficiency Testing scheme, the following factors should be
considered: <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
tests, measurements or calibrations involved should match the types of tests,
measurements or calibrations performed by the participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
availability to interested parties of details about the scheme design,
procedures for establishment of assigned values, instructions to
participants, statistical treatment of data, and the Final Summary Report; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
frequency at which the Proficiency Testing scheme is operated; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
suitability of the organizational logistics for the Proficiency Testing
scheme (e.g. timing, location, sample stability considerations, distribution
arrangements) relevant to the group of participants proposed for the Proficiency
Testing scheme; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
suitability of acceptance criteria (i.e. for judging successful performance
in the Proficiency Test);<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
costs; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
Proficiency Testing provider’s policy on maintaining participant’s
confidentiality; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
Proficiency Testing provider’s policy on maintaining participant’s
confidentiality; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
timescale for reporting of results and for analysis of performance data; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">j.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
characteristics that instil confidence in the suitability of Proficiency Test
items (e.g. homogeneity, stability, and, where appropriate, metrological
traceability to national or international standards); <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">k.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Its
conformance with this International Standard<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Some
Proficiency Testing schemes can include tests which are not exact match for
the tests performed by the participants (e.g. the use of different national
standard for the same determination), but it can still be technically
justified to participate in the Proficiency Testing scheme if the treatment
of the data allows for consideration of any significant differences in test
methodology or other factors. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">POLICIES
ON PARTICIPATION IN PROFICIENCY TESTING SCHEMES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="8" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.3.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">If
relevant, interested parties should document their policies for participation
in Proficiency Testing schemes; such documented policies should be publicly
available to laboratories and other interested parties. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.3.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Issues
which should be addressed in participation policies for specific Proficiency
Testing schemes include: <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Whether
participation in specific Proficiency Testing schemes is mandatory or
voluntary;<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
frequency of participation;<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
criteria used by the interested party to judge satisfactory or unsatisfactory
performance; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Whether
participants may be required to participate in follow– up Proficiency Testing
schemes if performance is judged to be unsatisfactory; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">How
the results of Proficiency Testing will be used in the Evaluation of
performance and subsequent decisions; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Details
of the interested party’s policy on preserving participant’s confidentiality.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">USE
OF PROFICIENCY TESTING BY PARTICIPANTS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="7" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.4.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
should draw their own conclusions about their performance from an evaluation
of the organization and design of the Proficiency Testing scheme. Reviews
should consider the relation between the Proficiency Testing scheme and the
needs of the participant’s customers. The information that should be taken
into consideration includes: <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
origin and character of Proficiency Test items; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
test and measurement methods used and, where possible, the assigned values
for particular test or measurement methods; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
organization of the Proficiency Testing scheme (e.g. the statistical design,
the number of replicates, the measurements, the manner of execution); <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
criteria used by the Proficiency Testing provider to evaluate the
participant’s performance; <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
relevant regulatory, accreditation or other requirements<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.4.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
should maintain their own records of performance in Proficiency Testing,
including the outcomes of investigations of any unsatisfactory results and
any subsequent corrective or preventive actions. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">USE
OF RESULTS BY INTERESTED PARTIES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="14" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Accreditation
Bodies <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="9" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
requirements for an accreditation body with regard to use of Proficiency
Testing are specified in ISO/IEC 17011:2004, 7.15<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Further
policies on Proficiency Testing relevant to the compliance of accreditation
bodies with requirements for membership in the ILAC mutual recognition
arrangement are specified in ILAC P–9 .<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
results from Proficiency Testing schemes are useful for both participants and
accreditation bodies. There are, however, limitations on the use of such
results to determine competence. Successful performance in a specific
Proficiency Testing scheme may represent evidence of competence for that
exercise, but many not reflect a random departure from a participant's normal
state of competence. It is for these reasons that Proficiency Testing should
not be the only tool used by accreditation bodies in their accreditation
process.<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.1.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For
participants reporting unsatisfactory results, the accreditation bodies
should have policies to<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that the participants investigate and comment on their performance within an
agreed time–frame, and take appropriate corrective action, <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">(where
necessary) ensure that the participant’s undertake any subsequent Proficiency
Testing to confirm that any corrective actions taken by them are effective,
and<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">(where
necessary) ensure that on–site evaluation of the participants is carried out
by appropriate technical assessors to confirm that corrective actions are
effective.<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.1.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
accreditation bodies should advise their accredited bodies of the possible
outcomes of unsatisfactory performance in a Proficiency Testing scheme. These
may range from continuing accreditation subject to successful attention to
corrective actions within agreed timeframes, temporary suspension of
accreditation for the relevant tests (subject to corrective action), through
to withdrawal of accreditation for the relevant tests.<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.1.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
accreditation bodies should have policies for feedback from accredited bodies
relating to action taken on the basis of results of Proficiency Testing
schemes, particularly for unsatisfactory performance. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Other
interested parties <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
may need to demonstrate their competence to other interested parties, such as
customers or in a subcontracting mandate. Proficiency Testing results, as
well as other quality control activities, can be used to demonstrate
competence, although this should not the only activity. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
testing data used to validate claims of competence are normally used by
organizations in conjunction with other evidence, such as accreditation. See
C.5.1.2.<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.6pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.5.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 323.5pt;" valign="top" width="431">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
is the responsibility of the participants to ensure that they have provided
all the appropriate information to interested parties wishing to evaluate the
participants as their competence. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.6<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">USE
OF PROFICIENCY TESTING BY REGULATORY BODIES <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr>
<td rowspan="5" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;"> </span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.6.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
results from Proficiency Testing schemes are useful for regulatory bodies
that need to evaluate the performance of participants covered by regulations.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.6.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">If
the Proficiency Testing scheme is operated by a regulatory body, it should be
operated in accordance with the requirements of this International Standard. <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" width="58">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">C.6.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Regulatory
bodies that use independent Proficiency Testing providers should<o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l12 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Seek
documentary evidence that the Proficiency Testing schemes comply with the
requirements of this International Standard before recognizing the
Proficiency Testing scheme, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l12 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Discuss
the participants the scope and operational parameters of the Proficiency
Testing schemes, in order that the participant’s performance may be judged
adequately in relation to the regulations. <o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div><p><span style="color: #01ffff; font-size: medium;"> </span></p>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-24597694849523173842023-02-20T21:38:00.002+08:002023-03-01T19:27:19.584+08:00Types of Proficiency Testing Scheme<p><span style="color: #01ffff; font-size: medium;"> </span></p><div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-table-layout-alt: fixed; mso-yfti-tbllook: 1184; width: 601px;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="7" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 451.1pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">TYPES OF
PROFICIENCY TESTING SCHEME</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">GENERAL<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td rowspan="5" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
testing has become an essential aspect of laboratory practice in all areas of
testing, calibration, and inspection. Proficiency testing schemes vary
according to the needs of the sector in which they are used, the nature of
the proficiency test items, the methods in use and the number of
participants. However, in their simplest form, most proficiency testing
schemes possess the common feature of comparison of results obtained by one
laboratory with those obtained by one or more different laboratories. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
nature of the test or measurement performed in Proficiency Testing Schemes
governs the method of comparing performance. There are three basic types of
laboratory examinations: quantitative, qualitative, and interpretive. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: Wingdings;"><span style="mso-char-type: symbol; mso-symbol-font-family: Wingdings;">â</span></span><span style="font-family: "Palatino Linotype", serif;"> The results
of a quantitative measurement are numerical and are reported on an interval
or a ratio scale. Test for quantitative measurement may vary in their
precision, trueness, analytical sensitivity, and specificity. In quantitative
proficiency testing schemes, numerical results are usually analysed
statistically. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: Wingdings;"><span style="mso-char-type: symbol; mso-symbol-font-family: Wingdings;">â</span></span><span style="font-family: "Palatino Linotype", serif;"> The results
of qualitative tests are descriptive and reported on a categorical or ordinal
scale, e.g. identity of microorganisms, or by identification of the presence
of a specific measurement (such as a drug or a grading of a characteristic).
Assessment of performance by statistical analysis may not be appropriate for
qualitative examinations. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: Wingdings;"><span style="mso-char-type: symbol; mso-symbol-font-family: Wingdings;">â</span></span><span style="font-family: "Palatino Linotype", serif;"> In
interpretive tests, the “proficiency testing items” is a test result (e.g.
descriptive morphology statement), a set of data (e.g. to determine a
calibration line) or other set of information (e.g. a case study), concerning
an interpretative feature of the participant’s competence. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Other
Proficiency Testing scheme have additional features depending on their
objective, as outlines in definition 3.7, Note 1, (a) to (h). Some common
applications of those types of Proficiency Testing are discussed below and
illustrated in Figure A.1. These schemes may be “single occasion” and
performed once, or “continuous” and performed at regular intervals. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">SEQUENTIAL
PARTICIPATION SCHEMES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td rowspan="10" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Sequential
Participation Schemes (sometimes known as measurement comparison schemes)
involve the Proficiency Test item being circulated successively from one
participant to the next (i.e., sequential participation), or occasionally
circulated back to the Proficiency Testing provider for rechecking. Model 1
in Figure A.1 provides a brief summary of this type of design, and the key
features are typically those described below.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
reference laboratory that is capable of providing a metrologically traceable
assigned value with sufficiently small measurement uncertainty and
reliability for the Proficiency Test item is used. For categorical or ordinal
properties, the assigned value should be determined by consensus of experts
or other authoritative source. It may be necessary for the Proficiency Test
item to be checked at specific stages during the conduct of the Proficiency
Testing scheme, in order to ensure that there is no significant change in the
assigned value.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
individual measurement results are compared with the assigned value
established by the reference laboratory. The coordinator should take into
account the claimed measurement uncertainty of each participant, or the
claimed level of expertise. It may be difficult to compare results on a group
basis as there may be relatively few participants having measurement
capabilities that closely match each other. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Schemes
involving sequential participation take time (in some cases, years) to
complete. This causes a number of difficulties, such as <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: Wingdings;"><span style="mso-char-type: symbol; mso-symbol-font-family: Wingdings;">â</span></span><span style="font-family: "Palatino Linotype", serif;"> Ensuring the
stability of the item; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: Wingdings;"><span style="mso-char-type: symbol; mso-symbol-font-family: Wingdings;">â</span></span><span style="font-family: "Palatino Linotype", serif;"> The strict
monitoring of the circulation among participants and the time allowed for
measurement by individual participants, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: Wingdings;"><span style="mso-char-type: symbol; mso-symbol-font-family: Wingdings;">â</span></span><span style="font-family: "Palatino Linotype", serif;"> The need to
supply feedback on individual performance during the scheme’s implementation,
rather than waiting until it finishes. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Proficiency
test items (measurement artifacts) used in this type of Proficiency test can
include, for example, measurement reference standards (e.g. resistors, micrometers,
and frequency counters) or, in medical programmes, histology slides with
confirmed diagnosis. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Schemes
that follow this design but that are limited to situations where a single
participant is tested independently are often called “measurement audits.” <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">In
some situations, the assigned value for a Proficiency Test item may be
determined by consensus, after all participants (or in some situations, a
subset of participants) have completed the measurement comparison<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">SIMULTANEOUS
PARTICIPATION SCHEMES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td rowspan="9" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.3.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">General<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Simultaneous
participation Proficiency Testing Scheme usually involve randomly selected
sub–samples from a source of material being distributed simultaneously to
participants for concurrent testing. In some schemes, participants are
required to take samples, which are then considered to be the Proficiency
Test items for analysis. After completion of the testing, the results are
returned to the Proficiency Testing Provider and compared with the assigned
value(s) to give an indication of the performance of the individual
participants and the group as a whole. Examples of Proficiency Test items
used in this type of scheme include food, body fluids, agricultural products,
water, soils, minerals and other environmental materials. In some cases,
separate portions of previously established reference materials are
circulated. Advice or educational comments are typically part of the report
returned to participants by the Proficiency Testing Provider with the aim of
promoting improvement in performance. Model 2 in Figure A.1 represents
typical Proficiency Testing schemes of this type, usually for testing
laboratories. Model 2 in Figure A.1 represents typical Proficiency Testing
schemes of this type, usually for testing laboratories. Model 3 presents a
type of scheme that is frequently used in conjunction with simultaneous
Proficiency Testing Schemes, for oversight or educational purposes. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">As
discussed in Annex B, assigned values for these Proficiency Testing schemes
may be determined in a variety of ways. However, either evaluations of
performance are based on consensus values form participants (all
participants, or a subset of “experts”) or evaluations can be on the basis of
independently determined assigned values. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Known
value schemes use assigned values that are determined independently of the
participants and involve preparations of Proficiency test items with a number
of known measurements or characteristics. Certified reference materials can
also be used in these schemes, as their certified value and measurement
uncertainty can used directly. A direct comparison can also be made between a
proficiency test item and a certified reference material under repeatability
conditions. However, care should be taken to ensure that the certified
reference material is closely comparable with a Proficiency test item.
Proficiency test items from previous proficiency testing rounds may be used
in this type of scheme if the item has demonstrated stability. One special
application of Proficiency Testing, often called “blind” Proficiency Testing
is where the Proficiency test item is indistinguishable from normal customer
items or samples received by the laboratory. This type of Proficiency Testing
can be difficult since it requires coordination with a normal laboratory
customer. In addition because, of unique packaging and shipping needs, bulk
processing is usually not feasible and homogeneity testing is difficult.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.3.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Split–level
Designs<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A
common design for Proficiency Testing is the “split–level” design, where
similar (but not identical) levels of measurement are included in two
separate Proficiency Test items. This design is used to estimate the
participant’s precision at a specific level of a measurement. It avoids
problems associated with replicate measurements on the same Proficiency Test
item, or with the inclusion of two identical Proficiency test items in the
same Proficiency Testing round. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.3.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Split–sample
Testing Schemes<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">One
special type of Proficiency Testing design that is often used by participants
customers and some regulatory bodies is the “split–sample design”<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Typically,
split–sample proficiency testing involves comparisons of the data produced by
small groups of participants (often only two). In these Proficiency Testing
schemes, samples of a product of a material are divided into two or more
parts, with each participant testing one part of the sample (see Figure A.1,
model 5). Uses for this type of scheme include identifying poor accuracy,
describing consistent bias and verifying the effectiveness of corrective
actions. This design may be used to evaluate one or both participants as
suppliers of testing services, or in cases where there are too few
participants for appropriate evaluation of results. Under such schemes, one
of the participants may be considered to operate at a higher metrological
level (i.e. lower measurement uncertainty), due to the use of reference
methodology and more advance equipment, etc. or through confirmation of its
own performance through satisfactory participation in a recognized
interlaboratory comparison scheme. Its results are considered to be the
assigned values in such comparisons and it may act as an advisory or mentor
laboratory to the other participants comparing split–image data with it. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.3.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Partial–process
schemes <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 43.6pt;" valign="top" width="58">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 373.1pt;" valign="top" width="497">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Special
types of Proficiency Testing involve the evaluation of participants abilities
to perform parts of the overall testing or measurement process. For example,
some existing Proficiency Testing Schemes evaluate participants abilities to
transform and report a given set of data (rather than conduct the actual test
or measurement), to make interpretations based on a given set of data or
Proficiency Testing items such as stained blood films for diagnosis, or to
take and prepare samples or specimens in accordance with a specification. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">EXTERNAL
QUALITY ASSESSMENT PROGRAMMES (EQA)<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">EQA
Programmes (such as those provided for laboratory medicine examinations)
offer a variety of interlaboratory comparison schemes based on this
traditional Proficiency Testing model, but with broader application to the
schemes described in A.2 and A.3 and illustrated in Figure A.1. Many EQA
Programmes are designed to provide insight into the complete path of workflow
of the laboratory, and not just the testing processes. Most EQA programmes
are continuous schemes that include long term follow up of laboratory
performance. A typical feature of EQA Programmes is to provide education to
participants and promote quality improvement. Advisory and educational
comments comprise part of the report returned to participants to achieve this
aim. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 32;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.4pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 416.7pt;" valign="top" width="556">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Some
EQA Programmes assess performance of pre–analytical and post–analytical phases
of testing, as well as the analytical phase. In such EQA Programmes, the
nature of the Proficiency Test item may differ significantly from that used
in traditional Proficiency Testing schemes. The “proficiency test item,
requiring the participant to select an appropriate approach to testing or
interpretation of results, and not just to perform the test. In “sample view”
schemes, participants may be required to provide the “’proficiency test items”
to the EQA provider (see Figure A.1, model 4). This may take the form of a
processed specimen or sample (e.g. stained slide or fixed tissue), laboratory
data (e.g. test results, laboratory reports or quality assurance/control
records) or documentation (e.g. procedures or method verification criteria). <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 33;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Model 1<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Sequential<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Model 2<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Simultaneous<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Model 3<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Interpretive<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Model 4<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Sample Review<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Model 5<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Split Sample<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 59.55pt; mso-yfti-irow: 34;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; height: 59.55pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce/procure
test items artefacts<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 59.55pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" valign="top" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce/procure
test items<o:p></o:p></span></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 59.55pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" valign="top" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce test items,
develop questionnaire, or case study<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 59.55pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" valign="top" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Determine test
items to be received from participants<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 59.55pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" valign="top" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
agree on analytes and sample types for comparison<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 35;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Determine
assigned value and its uncertainty<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Determine
assigned value and acceptable range of results<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Distribute
questionnaire, case sturdy or test items to participants<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Distribute
specifications to participants<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participant(s)
split appropriate samples and send to others<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 36;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Distribute to
first participant<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Distribute
test items to participants<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Receive
results and interpretations from participants<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Receive test
items from participants<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
share results or send to a coordinator<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 37;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Have
participants return item or send to next participant<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Receive
results and method information from participants<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Determine
acceptable criteria for responses and interpretations<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Determine
acceptable criteria for responses<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Graph or
otherwise compare results in this and previous studies<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 38;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Review
participant results and uncertainty for acceptability<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Compare
participants results and method information with acceptable range<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Compare
participant results and interpretation with criteria<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Compare
participants test items with criteria<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Compare with
pre– established criteria or discuss needs for action<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 39; mso-yfti-lastrow: yes;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce reports
and issue advisory /educational comments<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce
reports and issue advisory/educational comments<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce
reports and issue advisory/educational comments<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.2pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce
reports and issue advisory/educational comments<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 90.25pt;" width="120">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Produce
reports and records with any agreed conclusions, including data and graphs<o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-15657852276661675542023-02-20T21:14:00.001+08:002023-02-20T21:14:18.488+08:00ISO 17043<p style="text-align: center;"><span style="color: #01ffff; font-size: medium;"> <b style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;">CONFORMITY
ASSESSMENT – GENERAL REQUIREMENTS FOR PROFICIENCY TESTING</span></b></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><o:p> </o:p></span><b><span style="font-family: "Palatino Linotype", serif;">INTRODUCTION</span></b></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Interlaboratory
comparisons are widely used for a number of purposes and their use is
increasing internationally. Typical purposes for interlaboratory comparisons
include:</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Evaluation
of the performance of laboratories for specific tests or measurements and
monitoring laboratories continuing performance;</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Identification
of problems in laboratories and initiation of actions for improvement which,
for example, may be related to inadequate test or measurement procedure,
effectiveness of staff training and supervision, or calibration of equipment;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Establishment
of the effectiveness and comparability of test or measurement methods;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Provision
of additional confidence to laboratory customers;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Identification
of interlaboratory differences;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Education
of participating laboratories based on the outcomes of such comparisons;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Validation
of uncertainty claims;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Evaluation
of the performance characteristics of a method – often describe as
collaborative trials;</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Assignment
of values to reference materials and assessment of their suitability for use in
specific test or measurement procedures; and</span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo1; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Support
for statements of the equivalence of measurements of National Metrology
Institutes through “key comparisons” and supplementary comparisons conducted on
behalf of the International Bureau of Weight and Measurement (BIPM) and
associated regional metrology organizations.</span><span style="font-family: "Palatino Linotype", serif;"> </span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
Testing involves the use of interlaboratory comparisons for the determination
of laboratory performance, as listed in (a) to (g) above. Proficiency Testing
does not usually address (h) (i) and (j) because laboratory competence is
assumed in these applications, but these applications can be used to provide
independent demonstrations of laboratory competence. The requirements of this
International Standard can be applied to many of the technical planning and
operational activities for (h), (i) and (j).</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
need for ongoing confidence in laboratory performance is not only essential for
laboratories and their customers but also for other interested parties, such as
regulators, laboratory accreditation bodies and other organizations that
specify requirements for laboratories. ISO/IEC 17011 requires accreditation
bodies to take account of laboratories participation and performance in
proficiency testing. There is a growing need for proficiency testing for other
conformity assessment activities, such as inspection or product certification.
Most of the requirements in this International Standard apply to those evolving
areas, especially regarding management, planning and design, personnel,
assuring quality, confidentiality, and other aspects, as appropriate.</span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
International Standard has been prepared to provide a consistent basis for all
interested parties to determine the competence of organizations that provide
proficiency testing. In doing so it replaces both parts of ISO/IEC Guide
43:1997. ISO/IEC Guide 43 included not only guidance on development and
operation of proficiency testing and selection and use of proficiency testing.
This International Standard has preserved and updated the principles for the
operation of proficiency testing described in ISO/IEC Guide 43 and has retained
in Annexes A to C information on typical types of proficiency testing schemes,
guidance on appropriate statistical methods, selection and use of proficiency
testing schemes by laboratories, accreditation bodies, regulatory bodies and
other interested parties.</span></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184; width: 601px;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="4" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l30 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">1.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">SCOPE</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
International Standard specifies general requirements for the competence of
providers of proficiency testing schemes and for the development and
operation of proficiency testing schemes. These requirements are intended to
be general for all types of proficiency testing schemes, and they can be used
as a basis for specific technical requirements for fields of application. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l30 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">2.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">NORMATIVE
REFERENCE</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">ISO/IEC
17000:2004, Conformity assessment – Vocabulary and General Principles<o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">ISO/IEC
Guide 99:2007, International vocabulary of metrology – Basic and General
concepts and associated terms (VIM)<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l30 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">3.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">TERMS AND
DEFINITIONS</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For
the purposes of this document, the terms and definitions given in ISO/IEC
1700:2004, ISO/IEC Guide 99:2007 and the following apply,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.1<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Assigned
Value</span></b><span style="font-family: "Palatino Linotype", serif;">
– value attributed to a particular property of a proficiency test item.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.2<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Coordinator</span></b><span style="font-family: "Palatino Linotype", serif;"> – one or more
individuals with responsibility for organizing and managing all of the
activities involved in the operation of a proficiency testing scheme. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.3<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Customer</span></b><span style="font-family: "Palatino Linotype", serif;"> –
organization or individual for which a proficiency testing scheme is provided
through a contractual arrangement. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.4<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Interlaboratory
Comparison</span></b><span style="font-family: "Palatino Linotype", serif;">
– organization, performance and evaluation of measurement or tests on the
same or similar items by two or more laboratories in accordance with
predetermined conditions<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.5<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Outlier</span></b><span style="font-family: "Palatino Linotype", serif;"> – observation
in a set of data that appears to be inconsistent with the remainder of that
set (Note: An outlier can originate from a different population or be the
result of an incorrect recording or other gross error.) <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.6<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Participant</span></b><span style="font-family: "Palatino Linotype", serif;"> – laboratory,
organization or individual that receives proficiency test items and submits
results for review by the proficiency testing provider (Note: in some cases,
the participant can be an inspection body)<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td rowspan="11" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.7<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Proficiency
Testing</span></b><span style="font-family: "Palatino Linotype", serif;">
– evaluation of participant performance against pre – established criteria by
means of interlaboratory comparisons. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
1:</span></b><span style="font-family: "Palatino Linotype", serif;">
For the purposes of this International Standard, the term “proficiency
testing” is taken in its widest sense and includes, but not limited to: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Quantitative
Scheme</span></b><span style="font-family: "Palatino Linotype", serif;">
– where the objective is to quantify one or more measurement of the
proficiency test item; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Qualitative
Scheme</span></b><span style="font-family: "Palatino Linotype", serif;">
– where the objective is to identify or describe one or more characteristics
of the proficiency test item; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Sequential
Scheme</span></b><span style="font-family: "Palatino Linotype", serif;">
– where one or more proficiency test items are distributed sequentially for
testing or measurement and returned to the proficiency testing provider at
intervals; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Simultaneous
Scheme</span></b><span style="font-family: "Palatino Linotype", serif;">
– where proficiency test items are distributed for concurrent testing or
measurement within a defined time period; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Single
occasion exercise</span></b><span style="font-family: "Palatino Linotype", serif;">
– where proficiency test items are provided on a single occasion; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Continuous
Scheme</span></b><span style="font-family: "Palatino Linotype", serif;">
– where proficiency test items are provided at regular intervals;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Sampling</span></b><span style="font-family: "Palatino Linotype", serif;"> – where
samples are taken for subsequent analysis; and<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l24 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">Data
transformation and interpretation</span></b><span style="font-family: "Palatino Linotype", serif;"> – where sets of data or other
information are furnished, and the information is processed to provide an
interpretation (or other outcome). <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
2:</span></b><span style="font-family: "Palatino Linotype", serif;">
Some providers of proficiency testing in the medial area use the term
“External Quality Assessment (EQA)” for their proficiency testing schemes, or
for their broader programmes, or both (see Annex A). The requirements of this
International Standard cover only those EQA activities that meet the
definition of proficiency testing.<b><o:p></o:p></b></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.8<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Proficiency
Test Item</span></b><span style="font-family: "Palatino Linotype", serif;">
– sample, product, artefact, reference material, piece of equipment,
measurement standard, data set or other information used for proficiency
testing<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.9<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Proficiency
Testing Provider</span></b><span style="font-family: "Palatino Linotype", serif;">
– organization which takes responsibility for all tasks in the development
and operation of a proficiency testing scheme<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.10<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Proficiency
Testing Round</span></b><span style="font-family: "Palatino Linotype", serif;">
– single complete sequence of distribution of proficiency test items, and the
evaluation and reporting of results to the participants<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.11<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Proficiency
Testing Scheme</span></b><span style="font-family: "Palatino Linotype", serif;">
– proficiency testing designed and operated in one or more rounds for a
specified area of testing, measurement, calibration or inspection (Note: A
proficiency testing scheme might cover a particular type of test,
calibration, inspection or a number of tests, calibrations or inspection on
proficiency test items. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.12<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Robust
Statistical method</span></b><span style="font-family: "Palatino Linotype", serif;">
– statistical method insensitive to small departures from underlying
assumptions surrounding an underlying probabilistic model. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td rowspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.13<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Standard
Deviation for Proficiency Assessment</span></b><span style="font-family: "Palatino Linotype", serif;"> – measure of dispersion used in the
evaluation of results of proficiency testing, based on the available
information. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
1:</span></b><span style="font-family: "Palatino Linotype", serif;">
The standard deviation applies only to a ratio and different scale results. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
2:</span></b><span style="font-family: "Palatino Linotype", serif;">
Not all proficiency testing schemes evaluate proficiency based on the
dispersion of results.<b><o:p></o:p></b></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 32;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.14<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Subcontractor</span></b><span style="font-family: "Palatino Linotype", serif;"> –
organization or individual engaged by the proficiency testing provider to
perform activities specified in this International Standard and that affect
the quality of a proficiency testing scheme (Note: The term “subcontractor”
includes what many proficiency testing providers call collaborators. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 33;">
<td rowspan="9" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.15<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Metrological
Traceability</span></b><span style="font-family: "Palatino Linotype", serif;">
– property of a measurement result whereby the result can be related to a
reference through a documented unbroken chain of calibrations, each
contributing to the measurement uncertainty.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 34;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
1</span></b><span style="font-family: "Palatino Linotype", serif;">:
For this definition, a “reference” can be a definition of a measurement unit
through its practical realization, or a measurement procedure including the
measurement unit for a non–ordinal quantity, or a measurement standard. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 35;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
2</span></b><span style="font-family: "Palatino Linotype", serif;">:
Metrological traceability requires an established calibration hierarchy. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 36;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
3</span></b><span style="font-family: "Palatino Linotype", serif;">:
Specification of the reference must include the time at which this reference
was used in establishing the calibration hierarchy, along with any other
relevant metrological information about the reference, such as when the first
calibration in the calibration hierarchy was performed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 37;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
4</span></b><span style="font-family: "Palatino Linotype", serif;">:
For measurements with more than one input quantity in the measurement model,
each of the input quantity values should itself be metrologically traceable
and the calibration hierarchy involved may form a branched structure or a
network. The effort involved in establishing metrological traceability for
each input quantity value should be commensurate with its relative
contribution to the measurement result.<b><o:p></o:p></b></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 38;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
5</span></b><span style="font-family: "Palatino Linotype", serif;">:
Metrological traceability of a measurement result does not ensure that the
measurement uncertainty is adequate for a given purpose or that there is an
absence of mistakes. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 39;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
6</span></b><span style="font-family: "Palatino Linotype", serif;">:
A comparison between two measurement standards may be viewed as a calibration
if the comparison is used to check and, if necessary, correct the quantity
value and measurement uncertainty attributed to one of the measurement
standards. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 40;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
7</span></b><span style="font-family: "Palatino Linotype", serif;">:
the ILAC<sup>1</sup> considers the elements for confirming metrological
traceability to be an unbroken metrological traceability chain to an
international measurement standard or a national measurement standard, a
documented measurement uncertainty, a documented measurement procedure,
accredited technical competence, metrological traceability to the SI, and
calibration intervals (see ILAC P – 10:2002) <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><sup><span style="font-family: "Palatino Linotype", serif;">1</span></sup><span style="font-family: "Palatino Linotype", serif;"> International
Laboratory Accreditation Cooperation<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 41;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
8:</span></b><span style="font-family: "Palatino Linotype", serif;">
The abbreviated term “traceability” is sometimes used to mean “metrological
traceability” as well as other concepts, such as “sample traceability” or
“document traceability” or “instrument traceability” or “material
traceability”, where the history (“trace”) of an item is meant. Therefore,
the full term of “metrological traceability” is preferred if there is any
risk of confusion.<b><o:p></o:p></b></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 42;">
<td rowspan="5" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">3.16<o:p></o:p></span></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Measurement
uncertainty</span></b><span style="font-family: "Palatino Linotype", serif;">
– uncertainty of measurement; non– negative parameter characterizing the
dispersion of the quantity values being attributed to a measure, based on the
information used. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 43;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
1:</span></b><span style="font-family: "Palatino Linotype", serif;">
Measurement uncertainty includes components arising from systematic effects,
such as components associated with corrections and the assigned quantity
values of measurement standards, as well as the definitional uncertainty.
Sometimes estimated systematic effects are not corrected for but, instead
associated measurement uncertainty components are incorporated. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 44;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
2:</span></b><span style="font-family: "Palatino Linotype", serif;">
The parameter may be, for example, a standard deviation called standard
measurement uncertainty (or a specified multiple of it), or the half–width of
an interval, having a stated coverage probability.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 45;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
3:</span></b><span style="font-family: "Palatino Linotype", serif;">
Measurement uncertainty comprises, in general, many components. Some of these
may be evaluated by Type A evaluation of measurement uncertainty from the
statistical distribution of the quantity values from series of Type B
evaluation of measurement uncertainty, can also be characterized by standard
deviations, evaluated from probability density functions based on experience
or other information. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 46;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note
4:</span></b><span style="font-family: "Palatino Linotype", serif;">
In general, for a given set of information, it is understood that the
measurement uncertainty is associated with a stated quantity value attributed
to the measurement. A modification of this value results in a modification of
the associated uncertainty.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 47;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l30 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">4.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">TECHNICAL
REQUIREMENTS</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 48;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">GENERAL<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 49;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
development and operation of proficiency testing schemes shall be undertaken
by proficiency testing providers having competence to conduct interlaboratory
comparisons and access to expertise with the particular type of proficiency
test items. Proficiency testing providers or their subcontractors shall also
have competence in the measurement of the properties being determined. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 50;">
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note:
ISO/IEC 17025 or ISO 15189 can be used to demonstrate the competence of
proficiency testing provider’s laboratory, or the laboratory subcontracted to
perform tests or measurements related to the proficiency testing schemes. ISO
Guide 34 can be used to demonstrate the competence of producers of reference
materials that provide proficiency test items.<b><o:p></o:p></b></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 51;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">PERSONNEL<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 52;">
<td rowspan="20" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall have managerial and technical personnel
with necessary authority, resources and technical competence required to
perform their duties. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 53;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider’s management shall define the minimum levels of
qualifications and experience necessary for the key positions within its
organization and ensure those qualifications are met. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 54;">
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall use personnel who are neither employed by,
or under contract to it. Where contracted and additional technical and key
support personnel are used, the proficiency testing provider shall ensure
that such personnel are supervised and competent and that they work in
accordance with the management system. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 55;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note:</span></b><span style="font-family: "Palatino Linotype", serif;"> <span style="mso-tab-count: 1;"> </span>Where technical experts are used on an ad–hoc
basis or as part of an advisory or steering group (see 4.4.1.4), the
existence of f</span><span style="font-family: "Palatino Linotype", serif;">ormal
agreements though, for example, group terms of can be </span><span style="font-family: "Palatino Linotype", serif;">reference
or other means, considered to satisfy these requirements.</span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 56;">
<td rowspan="12" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall authorize specific personnel to: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 57;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Select
appropriate proficiency test items; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 58;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Plan
proficiency testing schemes;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 59;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Perform
particular types of sampling;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 60;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Operate
specific equipment;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 61;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Conduct
measurements to determine stability and homogeneity, as well as assigned
values and associated uncertainties of the measurements of the proficiency
test item; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 62;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Prepare,
handle and distribute proficiency test items; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 63;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Operate
the data processing system;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 64;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Conduct
statistical analysis; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 65;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Evaluate
the performance of proficiency testing participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 66;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Give
opinions and interpretations; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 67;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l5 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Authorize
the issue of proficiency testing reports. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 68;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall maintain up–to–date records of the
relevant authorization(s), competence, educational and professional
qualifications, training, skills, and experience of all technical personnel,
including contracted personnel. This information shall be readily available
and shall include the date on which competence to perform their assigned
tasks were assessed and confirmed.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 69;">
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall formulate the objectives with respect to
the education, training, and skill for each staff member involved with the
operation of the proficiency testing scheme. The proficiency testing provider
shall have a policy and procedures for identifying training needs and
providing training of personnel. The training programme shall be relevant to
the present and anticipated needs of the proficiency testing provider. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 70;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note:</span></b><span style="font-family: "Palatino Linotype", serif;"> <span style="mso-tab-count: 1;"> </span>It is advisable to consider the need to
retain staff periodically. </span><span style="font-family: "Palatino Linotype", serif;">Staff
training policies can take account of technological change, </span><span style="font-family: "Palatino Linotype", serif;">the
need to demonstrate on–going competence and aim at </span><span style="font-family: "Palatino Linotype", serif;">continual
skill upgrading.</span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 71;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.2.7<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall ensure that staff receive the necessary
training to ensure competent performance of measurements, operation of
equipment and any other activities which affect the quality of the
proficiency testing scheme. The effectiveness of training activities shall be
evaluated. <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note:
<span style="mso-tab-count: 1;"> </span>Objective measures can be used to
assess the attainment of competence. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 72;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">EQUIPMENT,
ACCOMODATION, AND ENVIRONMENT<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 73;">
<td rowspan="7" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.3.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall ensure that there is appropriate
accommodation for the operation of the proficiency testing scheme. This
includes facilities and equipment for proficiency test item manufacturing,
handling, calibration, testing, storage and despatch, for data processing,
for communications, and for retrieval of material and records. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 74;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.3.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall ensure that the environmental conditions
do not compromise the proficiency testing scheme or the required quality of
operations. Particular care shall be taken when operations are undertaken at
site away from the proficiency testing provider’s permanent facilities or are
undertaken by subcontractors. The technical requirements for accommodation
and environmental conditions that can affect the proficiency testing shall be
documented. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 75;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.3.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Assess
to and use of areas affecting the quality of proficiency testing schemes
shall be controlled. The proficiency testing provider shall determine the
extent of control based on its circumstances. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 76;">
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.3.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall identify environmental conditions that can
significantly influence the quality of the proficiency test items and any
testing and calibration carried out, including conditions that are required
by relevant specifications and measurement procedures. The proficiency
testing provider shall control and monitor these conditions and shall record
all relevant monitoring activities. Relevant proficiency testing activities
shall be stopped when the environmental conditions jeopardize the quality or
the operations of the proficiency testing scheme. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 77;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note:</span></b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-tab-count: 1;"> </span>Conditions can include, for example,
biological sterility, dust, </span><span style="font-family: "Palatino Linotype", serif;">electromagnetic
disturbances, radiation, humidity, electrical </span><span style="font-family: "Palatino Linotype", serif;">supply,
temperature, and sound and vibration levels, as appropriate to the technical
activities concerned.</span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 78;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.3.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">There
shall be effective separation between neighbouring areas in which there are
incompatible activities. Action shall be taken to prevent
cross–contamination. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 79;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.3.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
testing providers shall ensure that performance characteristics of laboratory
methods and equipment used to confirm the content, homogeneity and stability
of proficiency testing are appropriately validated and maintained. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 80;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">DESIGN
OF PROFICIENCY TESTING SCHEMES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 81;">
<td rowspan="81" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Planning<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 82;">
<td rowspan="37" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall identify and plant those processes which
directly affect the quality of the proficiency testing scheme and shall
ensure that they are carried out in accordance with prescribed measures.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 83;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note:</span></b><span style="font-family: "Palatino Linotype", serif;"> <span style="mso-tab-count: 1;"> </span>Stakeholders interests can be considered in
developing a plan and relevant information.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 84;">
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall not subcontract the planning of the
proficiency testing scheme (see 5.5.2)<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 85;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note:
</span></b><span style="font-family: "Palatino Linotype", serif;">The
proficiency testing provider can utilize advice or </span><span style="font-family: "Palatino Linotype", serif;">assistance
from any advisors, experts, or steering group </span><span style="font-family: "Palatino Linotype", serif;">(See
4.4.1.4)</span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 86;">
<td rowspan="22" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.1.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall document a plan before commencement of the
proficiency testing scheme that addresses the objectives, purpose and basic
design of the proficiency testing scheme, including the following information
and, where appropriate, reasons for its selection or exclusion: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 87;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
name and address of the proficiency testing provider;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 88;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
name, address and affiliation of the coordinator and other personnel involved
in the design and operation of the proficiency testing scheme; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 89;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
activities to be subcontracted and the names and address of subcontractors
involved in the operation of the proficiency testing scheme; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 90;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Criteria
to be met for participation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 91;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
number and type of expected participants in the proficiency testing scheme; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 92;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Selection
of the measurements or characteristics of interest information on what the
participants are to identify, measure, or test for in the specific
proficiency testing round; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 93;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
description of the range of values or characteristics, or both, to be expected
for the proficiency test items; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 94;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
potential major sources of errors involved in the area of proficiency testing
offered; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 95;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Requirements
for the production, quality control, storage and distribution of proficiency
test items; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 96;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Reasonable
precautions to prevent collusion between participants or falsification of
results, and procedures to be employed if collusion or falsification of
results is suspected; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 97;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
description of the information which is to be applied to participants and the
time schedule for the various phases of the proficiency testing scheme; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 98;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">l.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">For
continuous proficiency testing schemes, the frequency or dates upon which
proficiency test items are to be distributed to participants, the deadlines
for the return of results by participants and, where appropriate, the dates
on which testing, or measurement is to be carried out by participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 99;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">m.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
information on methods or procedures which participants need to use to
prepare the test material and perform the tests or measurements; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 100;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">n.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Procedures
for the test or measurement methods to be used for the homogeneity and
stability testing of proficiency test items and, where applicable, to
determine their biological viability; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 101;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">o.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Preparation
of any standardized reporting formats to be sued by participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 102;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">p.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
detailed description of the statistical analysis to be used; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 103;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">q.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
origin, metrological traceability and measurement uncertainty of any assigned
values;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 12.5pt; mso-yfti-irow: 104;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 12.5pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">r.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Criteria
for the evaluation of performance of participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 105;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">s.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
description of the data, interim reports or information to be returned to
participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 106;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l19 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">t.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
description of the extent to which participants results, and the conclusion
that will be based on the outcome of the proficiency testing scheme, are to
be made public; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 107;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif; text-indent: -18pt;">u.<span style="font-family: "Times New Roman"; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span></span><span dir="LTR" style="text-indent: -18pt;"></span><span style="font-family: "Palatino Linotype", serif; text-indent: -18pt;">Actions
to be taken in the case of lost or damaged proficiency test items.</span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 108;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.1.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall have access to the necessary technical
expertise and experience in the relevant field of testing, calibration,
sampling or inspection, as well as statistics. This may be achieved, if
necessary, by establishing an advisory group (named as appropriate). <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 109;">
<td rowspan="10" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.1.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Technical
expertise shall be used, as appropriate, to determine matter such as the
following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 110;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Planning
requirements as listed in 4.4.1.3; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 111;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Identification
and resolution of any difficulties expected in the preparation and
maintenance of homogenous proficiency test items, or in the provision of a
stable assigned value for a proficiency test item; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 112;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Preparation
of detailed instruction for participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 113;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Comments
on any technical difficulties or other remarks raised by participants in
previous proficiency testing rounds; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 114;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Provision
of advice in evaluating the performance of participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 115;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Comments
on the results and performance of participants as a whole and, where
appropriate, groups of participants or individual participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 116;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Provisions
of advice for participants (within limits of confidentiality), either
individually or within the report; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 117;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Responding
to feedback from participants; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 118;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Planning
or participating in technical meetings with participants. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 119;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Preparation
of Proficiency Test items<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 120;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall establish and implement procedures to
ensure that proficiency test items are prepared in accordance with the plan
described in 4.4.1<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 121;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note:
It is advisable that the proficiency testing provider give due consideration
to the preparation of sufficient number of proficiency test items, in order
to allow for the need to replace any such Proficiency Test items lost or
damaged during distribution or intended to be provided for use after the
results of the Proficiency Testing Scheme have been evaluated. Such uses can
include training aids for participants or use as a Reference Material.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 122;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall establish and implement procedures to
ensure appropriate acquisition, collection, preparation, handling, storage
and, where required, disposal of all Proficiency Test items. The procedures
shall ensure that materials used to manufacture Proficiency Test items are obtained
in accordance with relevant regulatory and ethical requirements. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 123;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" valign="top" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
Test items should match in terms of matrix, measurements, and concentrations,
as closely as practicable, the type of items or materials encountered in
routine testing or calibrations. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 124;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" valign="top" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.2.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
Proficiency Testing schemes that require participants to prepare or
manipulate, or both prepare and manipulate, the Proficiency test item and
submit it to the Proficiency Testing provider, the proficiency testing
provider shall issue instructions for preparation, packaging and transport of
the proficiency test item. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 125;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Homogeneity
and Stability<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 126;">
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Criteria
for suitable homogeneity and stability shall be established and shall be
based on the effect that inhomogeneity and instability will have on the
evaluation of the participant’s performance. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 127;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 1:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
requirements in this subclause are intended to ensure that every participant
receives comparable proficiency test items, and that these proficiency test
items remain stable throughout the Proficiency testing. Careful planning,
manufacture and shipping are necessary to achieve this, and testing is
usually needed to confirm it. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 128;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 2:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
some cases, it is not feasible for Proficiency Test items to be subjected to
homogeneity and stability testing. Such cases would include, for example,
when limited material is available to prepare proficiency testing items. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 129;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 3:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
some cases, materials that are not sufficiently homogenous or stable are the
best available; in such cases, they can still be useful as Proficiency Test
items, provided that the uncertainties of the assigned values or the
evaluation of results take due account of this (see B.3.1.3 and ISO
13528:2005, Annex B)<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 130;">
<td rowspan="9" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 4:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Considerations
for homogeneity and stability are further discussed in ISO Guide 34, ISO
Guide 35 and ISO 13528<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 131;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
procedures for the assessment of homogeneity and stability shall be
documented and conducted, where applicable, in accordance with appropriate
statistical designs. Where possible, the proficiency testing provider shall
use a statistically random selection of a representative number of
Proficiency Test items for the whole batch of test material to assess the
homogeneity of the material. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 132;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
some cases, the use of a random stratified or systematic selection of
Proficiency test items from the whole batch is more appropriate. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 133;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.3.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
assessment of homogeneity shall normally be performed after the Proficiency
Test items have been packaged in the Final Form and before distribution or
participants unless, for example, stability studies indicate that they should
be stored in bulk form. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 134;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 1:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Homogeneity
can be demonstrated prior to packaging where no influence of packaging is
reasonably expected <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 135;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 2:<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">On
some occasions, homogeneity testing cannot be carried out prior to
distribution of practical, technical, or logistical reasons. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 136;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.3.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
test items shall be demonstrated to be sufficiently stable to ensure that
they will not undergo any significant change throughout the conduct of the
Proficiency Testing, including storage and transport conditions. When this is
not possible, the stability shall be quantified and considered as an
additional component of the measurement uncertainty associated with the
assigned value of the Proficiency Test item, and/or taken into account in the
Evaluation criteria. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 137;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.3.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
Proficiency Test items form previous rounds are retained for future use, the
property values to be determined in the proficiency testing scheme shall be
confirmed by the Proficiency Testing provider prior to distribution. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 138;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.3.6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
circumstances where homogeneity and stability testing is not feasible, the
Proficiency Testing provider shall demonstrate that the procedures used to
collect, produce, package and distribute the Proficiency Test items are
sufficient for the purpose of the Proficiency Testing. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 139;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Statistical
Design<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 140;">
<td rowspan="14" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.4.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Statistical
design shall be developed to meet the objectives of the scheme, based on the
nature of the data (quantitative or qualitative, including ordinal and
categorical), statistical assumptions, the nature of errors, and the expected
number of results (see B.3.2.2). <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 141;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Statistical
design covers the process of planning, collection, analysis and reporting of
the Proficiency Testing scheme date. Statistical designs are often based on
stated objectives for the Proficiency Testing scheme, such as detection of
certain types of errors with specified power or determination of assigned
values with specified measurement uncertainty. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 142;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Data
analysis methods could vary from the very simple (e.g. descriptive
statistics) to the complex, using statistical models with probabilistic
assumptions or combinations of results for different Proficiency Test items. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 143;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
cases where the Proficiency Testing scheme design is mandated by a
specification given by, for example, a customer, regulatory authority or
accreditation body, the statistical design and data analysis methods can be
taken directly from the specification. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 144;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
the absence of reliable information needed to produce a statistical design, a
preliminary interlaboratory comparison can be used. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 145;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.4.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall document the statistical design and data
analysis methods to be used to identify the assigned value and evaluate
participant results and shall provide a description of the reasons for their
selection and assumptions upon which they are based. The Proficiency Testing
provider shall be able to demonstrate that statistical assumptions are
reasonable, and that statistical analysis are carried out in accordance with
prescribed procedures. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 146;">
<td rowspan="8" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.4.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
designing a statistical analysis, the Proficiency Testing provider shall give
careful consideration to the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 147;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
accuracy (trueness and precision) as well as the measurement uncertainty
required or expected for each measurement or characteristic in the
Proficiency Testing; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 148;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
minimum number of participants in the Proficiency Testing scheme needed to
meet the objectives of the statistical design; in cases where there is an
insufficient number of participants to meet these objectives or to produce
statistically meaningful analysis of results, the proficiency testing
provider shall document, and provide to participants, details of the
alternative approaches used to assess participant performance; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 149;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
relevance of significant figures to the reported result, including the number
of decimal places; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
number of Proficiency test items to be tested or measured and the number of
repeat tests, calibrations or measurements to be conducted on each
Proficiency Test item or for each determination; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 150;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
procedure used to establish the standard deviation assessment or other
evaluation criteria; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 151;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Procedures
to be used to identify or handle outliers, or both; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 152;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Where
relevant, the procedures for the evaluation of values excluded from
statistical analysis; and<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 153;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l33 level1 lfo7; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Where
appropriate, the objectives to be met for the design and the frequency of
Proficiency Testing rounds. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 154;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.5<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Assigned
Values<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 155;">
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.5.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall document the procedure for determining the
assigned values for the measurement or characteristics in a particular
Proficiency Testing scheme. This procedure shall consider the metrological
traceability and measurement uncertainty required to demonstrate that the
Proficiency testing scheme is fit for its purpose. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 156;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Metrological
traceability is not always possible or appropriate<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 157;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.5.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
testing schemes in the area of calibration shall have assigned values with
metrological traceability, including measurement uncertainty. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 158;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.5.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
testing schemes in the area other than calibration, the relevance, needs and
feasibility for metrological traceability and associated measurement
uncertainty of the assigned value shall be determined by taking into account
specified requirements of participants or other interested parties, or by the
design of the Proficiency Testing scheme. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 159;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
required metrological traceability chain can differ depending on the type of
Proficiency Test item, the measurement or characteristic, and the availability
of traceable calibrations and reference materials. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 160;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.5.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
consensus value is used as the assigned value (see Annex B), the Proficiency
Testing provider shall document the reason for that selection and shall
estimate the uncertainty of the assigned value as described in the plan for
the Proficiency Testing scheme. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 161;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.4.5.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall have a policy regarding the disclosure of
assigned values. The policy shall ensure that participants cannot gain
advantage from early disclosure. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 162;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.5<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">CHOICE
OF METHOD OR PROCEDURE<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 163;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.5.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
shall normally be expected to use the test method, calibration, or
measurement procedure of their choice, which should be consistent with their
routine procedures. The Proficiency Testing provider may instruct
participants to use a specified method in accordance with the design of the
Proficiency Testing Scheme. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 164;">
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.5.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
participants are permitted to use a method of their choice, the proficiency
testing provider shall: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 165;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l29 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Have
a policy and follow a procedure regarding comparison of results obtained by
different test or measurement methods. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 166;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l29 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Be
aware of which different test or measurement methods for any measurement are
technically equivalent and take steps to assess participant’s results using
these methods accordingly. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 167;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">OPERATION
OF PROFICIENCY TESTING SCHEMES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 168;">
<td rowspan="25" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Instructions
for participants<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 169;">
<td rowspan="11" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall give participants prior notice before
sending proficiency test items, providing the date on which the Proficiency
Test items are likely to arrive or to be dispatched, unless the design of the
Proficiency Testing Scheme makes it inappropriate to do so. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 170;">
<td rowspan="10" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing Provider shall give detailed documented instructions to
all participants. Instructions to participants shall include: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 171;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
necessity to treat proficiency test items in the same manner as the majority
of routinely tested samples (unless there are particular requirements of the
proficiency testing scheme which require departure from this principle);<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 172;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Details
of factors which could influence the testing or calibration of the
Proficiency Test items, e.g. the nature of the Proficiency Test items,
conditions of storage, whether the Proficiency Testing Scheme is limited to
selected test methods, and the timing of the testing or measurement; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 173;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Detailed
procedure for preparing or conditioning, or both preparing and conditioning,
of the proficiency test items before conducting the tests or calibrations; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 174;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
appropriate instructions on handling the Proficiency Test items, including
any safety requirements; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 175;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
specific environmental conditions for the participants to conduct tests or
calibrations, or both, and, if relevant, any requirements for the
participants to report relevant environmental conditions during the time of
the measurement; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 176;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Specific
and detailed instructions on the manner or recording and reporting test or
measurement results and associated uncertainties. If the instructions include
reporting of the uncertainty of the reported result or measurement, this
shall include the coverage factor and, whenever practicable, the coverage probability.
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note: This instruction usually
includers parameters such as the unites of measurement, the number of
significant figures or decimal places and reporting basis (e.g. on dry
weight, or “as received”). <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 177;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
latest date for the provider to receive the Proficiency Testing or
measurement results for analysis; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 178;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Information
on the contact details of the Proficiency Testing provider for enquiries; and
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 179;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo9; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Instructions
on return of the Proficiency Test items, when applicable. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 180;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
Test items handling and storage<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 181;">
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall ensure that proficiency test items are
appropriately identified and segregated and cannot become contaminated or
degraded, from the time of preparation to their distribution to participants.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 182;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency testing provider shall provide secure storage areas or stock
rooms, or both, which prevent damage or deterioration of any proficiency test
item between preparation and distribution. Appropriate procedures for
authorizing despatch to, and receipt from, such areas shall be defined. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 183;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
appropriate, the condition of stored or stocked proficiency test items,
chemicals and materials shall be assessed at specified intervals during their
storage life in order to detect possible deterioration. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 184;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.2.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
potentially hazardous Proficiency Test items, chemicals and materials are
used, facilities shall be available to ensure their safe handling,
decontamination and disposal.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 185;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Packaging,
Labelling and Distribution of Proficiency Test items<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 186;">
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall control packaging and labelling processes
to the extent necessary to ensure conformity with relevant national,
regional, or international safety and transport requirements. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 187;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;">Note:</span></b><span style="font-family: "Palatino Linotype", serif;"> The proper
distribution of Proficiency test items can present severe problems for some
types of material, e.g. those which require uninterrupted storage in cold
conditions or which should be exposed to X–rays, shock or vibration. Most
types of chemical materials would benefit from air–tight packaging to avoid
contamination by atmospheric contaminants, e.g. fuel vapours or engine
exhaust gases which can be encountered during transport.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 188;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall specify relevant environmental conditions
for the transport of Proficiency Test items. Where relevant, the proficiency
testing provider shall monitor the pertinent environmental conditions of the
proficiency test item during transport and assess the impact of environmental
influences on the Proficiency Test item. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 189;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.3.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
Proficiency Testing Schemes where participants are required to transport the
Proficiency Test items to other participants, documented instructions for
this transport shall be supplied. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 190;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.3.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall ensure that labels are securely attached
to the packaging of individual Proficiency Test items and are designed to
remain legible and intact throughout the Proficiency Testing round. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 191;">
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.6.3.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall follow a procedure to enable the
confirmation of delivery of the Proficiency Test items. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 192;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note:
This could be achieved in accordance with 4.6.1.1 by asking participants to
inform the Proficiency Testing provider if Proficiency Test items have not
been received in<span style="mso-spacerun: yes;"> </span>line with the
schedule of dates provided.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 193;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">DATA
ANALYSIS AND EVALUATION OF PROFICIENCY TESTING SCHEME RESULTS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 194;">
<td rowspan="19" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Data
Analysis and Records<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 195;">
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">All
data processing equipment and software shall be validated with procedures
before brought into use. Computer system maintenance shall include a back–up
process and system recovery plan. The results of such maintenance and
operational checks shall be recorded. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 196;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Results
received from participants shall be recorded and analysed by appropriate
methods. Procedures shall be established and implemented to check the
validity of data entry, data transfer, statistical analysis and reporting. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 197;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.1.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Data
analysis shall generate summary statistics and performance statistics, and
associated information consistent with the statistical design of the
Proficiency Testing Scheme<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 198;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.1.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
influence of outliers on summary statistics shall be minimized using robust
statistical methods or appropriate tests to detect statistical outliers. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 199;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.1.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing Provider shall have documented criteria and procedures
for dealing with test results that may be inappropriate for statistical
evaluation, e.g. miscalculations, transpositions and other gross errors. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 200;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.1.6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing Provider shall have documented criteria and procedures to
identify and manage Proficiency Test items that have been distributed and are
subsequently found to be unsuitable for Performance Evaluation, e.g. because
of inhomogeneity, instability, damage or contamination. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 201;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Evaluation
of Performance<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 202;">
<td rowspan="11" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall use valid methods of evaluation which meet
the purpose of the Proficiency Testing Scheme. The methods shall be
documented and include a description of the basis for the evaluation. The
evaluation of performance shall not be subcontracted (see 5.5.2)<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 203;">
<td rowspan="9" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.7.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
appropriate for the purpose of the Proficiency Testing Scheme, the
proficiency testing provider shall provide expert commentary on the
performance of participants with regard to the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 204;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Overall
performance against prior expectations, taking measurement uncertainties into
account; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 205;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Variation
within and between participants, and comparisons with any previous
Proficiency Testing rounds, similar Proficiency Testing Schemes, or published
precision data; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 206;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Variation
between methods or procedures; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 207;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Possible
source of error (with reference to outliers) and suggestions for improving
performance; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 208;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Advice
and educational feedback to participants as part of the continual improvement
procedures of participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 209;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Situations
where unusual factors make evaluation of results and commentary on
performance impossible. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 210;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
other suggestions, recommendations, or general comments; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 211;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Conclusions
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 212;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
can be useful to provide individual summary sheets for participants
periodically during or after completion of a particular Proficiency Testing
Scheme. These can include updated summaries of performance for individual
participants over successive Proficiency Testing rounds of a continuous
Proficiency Testing Scheme. Such summaries can be further analysed and trends
highlighted, if required. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 213;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.8<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Reports<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 214;">
<td rowspan="31" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.8.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Proficiency
Test reports shall be clear and comprehensive and include data covering the
results of all participants, together with indication of the performance of
individual participants. The authorization of the final report shall not be
subcontracted (see 5.5.2). <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 215;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
all original data cannot be reported to participants, a summary of the
results, e.g. in tabulated or graphical form, can be supplied. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 216;">
<td rowspan="21" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.8.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Reports
shall include the following, unless it is not applicable or the Proficiency
Testing Provider has valid reasons for not doing so: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 217;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">the
name and contact details for the Proficiency Testing Provider; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 218;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">the
name and contact details for the coordinator; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 219;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">the
name(s), function(s), and signature(s) or equivalent identification of
person(s) authorizing the report; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 220;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">an
indication of which activities are subcontracted by the Proficiency Testing
provider; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 221;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">the
date of issue and status (e.g. preliminary, interim, or final) of the report;
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 222;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">page
numbers and a clear indication of the end of the report; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 223;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">a
statement of the extent to which results are confidential; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 224;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">the
report number and clear identification of the Proficiency Testing Scheme; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 225;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">a
clear description of the Proficiency Test items used, including necessary
details of the Proficiency Test item’s preparation and homogeneity and
stability assessment; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 226;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">the
Participant’s results; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 227;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">statistical
data and summaries including assigned values and range of acceptable results
and graphical displays; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 228;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">l.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">procedures
used to establish any assigned value; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 229;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">m.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">details
of the metrological traceability and measurement uncertainty of any assigned
value; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 230;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">n.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">procedures
used to establish the standard deviation for Proficiency Assessment, or other
criteria for evaluation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 231;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">o.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">assigned
valued and summary statistics for test methods/procedures used by each group
of participants (if different methods are used by different groups of
participants); <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 232;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">p.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">comments
on participants’ performance by the Proficiency Testing provider and
technical advisers; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 233;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">q.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">information
about the design and implementation of the Proficiency Testing Scheme; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 234;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">r.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Procedures
used to statistically analyse the data; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 235;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">s.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Advice
on the interpretation of the statistical analysis; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 236;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">t.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Comments
or recommendations, based on the outcomes of the Proficiency Testing round<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 237;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">For
continuous Proficiency Testing Schemes, it can be sufficient to have simpler
reports, such that many of the elements in this clause could be excluded from
routine reports, but included in Proficiency Testing Scheme protocols or in
periodic Summary Reports that are available to participants. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 238;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.8.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Reports
shall be made available to participants within planned timescales. In
Sequential Proficiency Testing Schemes, e.g. where the turn–around time may
be very long, and in schemes involving perishable materials, preliminary or
anticipated results may be provided before final results are disclosed.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 239;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
allows for early investigation of possible error. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 240;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.8.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall have a policy for the use of reports by individuals
and organizations.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 241;">
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.8.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
it is necessary to issue a new or amended report for Proficiency Testing
Scheme, this shall include the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 242;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
unique identification; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 243;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
reference to the original report that it replaces or amends; and<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 244;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l31 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
statement concerning the reason for the amendment or </span><span style="font-family: "Palatino Linotype", serif;">re–issue.</span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 245;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.9<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Communication
with participants <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 246;">
<td rowspan="5" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.9.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall make detailed information available about
the Proficiency Testing Scheme. This shall include: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Relevant
details of the scope of the Proficiency Testing Scheme; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Any
fees for participation; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Documented
eligibility criteria for participation; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Confidentiality
arrangement; and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo13; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Details
of how to apply <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 247;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.9.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
shall be advised promptly by the Proficiency Testing Provider of any changes
in Proficiency Testing Scheme design or operation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 248;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.9.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">There
shall be documented procedures for enabling participants to appeal against
the evaluation of their performance in a Proficiency Testing Scheme. The
availability of this process shall be communicated to Proficiency Testing
Scheme participants. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 249;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.9.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Relevant
records of communications with participants shall be maintained and retained,
as appropriate. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 250;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.9.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">If
the Proficiency Testing Provider issues statements of participation or
performance, they shall contain sufficient information to not be misleading.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 251;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.10<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Confidentiality<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 252;">
<td rowspan="5" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.10.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
identity of participants in a Proficiency Testing Scheme shall be
confidential and known only to persons involved in the operation of the
Proficiency Testing Scheme, unless the participant waives confidentiality. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 253;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.10.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">All
information supplied by a participant to the Proficiency Testing Provider
shall be treated as confidential. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 254;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Participants
can elect to waive confidentiality within the Proficiency Testing Scheme for
the purposes of discussion and mutual assistance, e.g. to improve
performance. Confidentiality can also be waived by the participant for
regulatory or recognition purposes. In most instances, the proficiency
testing results can be provided to the relevant authority by the participants
themselves.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 255;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.10.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
an interested party requires the Proficiency Testing results to be directly
provided by the Proficiency Testing Provider, the participants shall be made
aware of the arrangement in advance of participation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 256;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">4.10.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
exceptional circumstances, when a regulatory authority Proficiency Testing
results to be directly provided to the authority by the Proficiency Testing
provider, the affected participants shall be notified of this action in
writing. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 257;">
<td colspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l30 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">5.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;">
</span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype", serif;">MANAGEMENT
REQUIREMENTS</span></b><b><span style="font-family: "Palatino Linotype", serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 258;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">ORGANIZATION<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 259;">
<td rowspan="18" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.1.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing Provider, or the organization of which it is part, shall
be an entity that is legally identifiable and accountable. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 260;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.1.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
is the responsibility of the Proficiency Testing provider to carry out its
proficiency testing operations in such a way as to meet the requirements of
this International Standard and to satisfy the needs of the participants,
regulatory authorities and organization providing recognition. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 261;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.1.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
management system shall cover work carried out in the Proficiency Testing
provider’s permanent facilities, at sites away from its permanent facilities,
and is associated temporary facilities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 262;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.1.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">If
the Proficiency Testing provider is part of an organization performing other
activities, then the Proficiency Testing provider shall identify the
responsibilities of key personnel in the organization that have an
involvement in or could have influence on the Proficiency Test activities, in
order to identify potential conflicts of interest. Where potential conflicts
of interest are identified, procedures shall be put in place to ensure that
all activities of the Proficiency Testing provider are conducted with impartiality.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 263;">
<td rowspan="12" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.1.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 264;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Have
managerial and technical personnel who, irrespective of other
responsibilities, have the authority and resources needed to carry out their
duties, including the implementation, maintenance and improvement of the
management system, and to identify the occurrence of departures from the
management system or from the procedures for providing Proficiency Testing
Schemes, and to initiate actions to prevent or minimize such departures; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 265;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Have
arrangements to ensure that its management and personnel are free from any
undue internal or external commercial, financial and other pressures that may
adversely affect the quality of their work; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 266;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Have
policies and procedures to ensure the protection of its participants’
confidential information and proprietary rights, including procedures for
their protection during electronic storage and transmission; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 267;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Have
policies and procedures to avoid involvement in any activities that might
diminish confidence in its competence, impartiality, judgement or operational
integrity; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 268;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Define
the organization and management structure, its place in any parent
organization, and the relationships between quality management, technical
operations and support services; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 269;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Specify
the responsibility, authority, interrelationships and required competence of
all personnel who manage, perform or verify work affecting the quality of the
operation of Proficiency Testing schemes; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 270;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Ensure
that the personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the objectives of
the management system; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 271;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Provide
adequate supervision of technical staff, including trainees, by persons
familiar with procedure for each activity; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 272;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Have
technical management which has overall responsibility for the technical
operations and the provision of the resources needed to ensure the required
quality of Proficiency Testing Schemes, including access to the necessary
technical expertise in the relevant field of testing, calibration or
inspection, as well as statistics, as indicated in 4.4.1.4; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 273;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Appoint
a member of staff as Quality Manager (names as appropriate) who, irrespective
of other duties and responsibilities, shall have defined responsibility and
authority for ensuring that the management system is implemented and followed
at all times; the Quality Manager shall have direct access to the highest
level of management at which decisions are taken on Proficiency Testing
provider’s policies or resources; and<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 274;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">k.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Appoint
deputies for key managerial personnel<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 275;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
Proficiency Testing providers have a smaller number of personnel, individuals
can have more than one function and it can be impractical to appoint deputies
for all major functions. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 276;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.1.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Top
management shall ensure that appropriate communication processes are
established within the organization and that communication takes place
regarding the effectiveness of the management system. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 277;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">MANAGEMENT
SYSTEM<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 278;">
<td rowspan="14" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall establish, implement and maintain a
management system appropriate to its scope of activities, including the type,
range and volume of Proficiency Testing that it provides. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 279;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall define and document its policies,
programmes, procedures, and instructions to the extent necessary to assure
the quality of all aspects of Proficiency Testing. The system’s documentation
shall be communicated to, understood by, available to, and implemented by the
appropriate personnel. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 280;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">These
aspects include, but are not limited to, proficiency test item quality (e.g.
homogeneity and stability), characterization (e.g. equipment calibration and
method validation), assignment of property values (e.g. use of appropriate
statistical procedures), evaluation of participant performance, distribution
of Proficiency test items, storage and transport procedures, statistical
treatment of test results, and reporting. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 281;">
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider’s management system policies related to quality,
including a quality policy statement, shall be defined in a quality manual
(names as appropriate). The overall objectives shall be established and
reviewed during management review. The quality policy statement shall be
issued under the authority of top management. It shall include at least the
following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 282;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
management’s commitment to the quality of its Proficiency Testing services to
participants and other customers; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 283;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
management’s statement of the standard of service; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 284;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
purpose of the management system related to quality; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 285;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
requirement that all personnel concerned with the Proficiency Testing
activities familiarize themselves with the quality documentation and
implement the policies and procedures in their work; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 286;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l21 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
management’s commitment to comply with this International Standard and to
continually improve the effectiveness of the management system. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 287;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Top
management shall provide evidence of commitment to the development and
implementation of the management system and to continually improving its
effectiveness. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 288;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Top
management shall communicate to the organization the importance of meeting
customer requirements, as well as statutory and regulatory requirements. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 289;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
quality manual shall include or make reference to the supporting procedures,
including technical procedures. It shall outline the structure of the
documentation used in the management system. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 290;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.7<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
roles and responsibilities of technical management and the Quality Manager,
including their responsibility for ensuring compliance with this
International Standard, shall be defined in the quality manual.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 291;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.2.8<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Top
management shall ensure that the integrity of the management system is
maintained when changes to the management system are planned and implemented.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 292;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">DOCUMENT
CONTROL <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 293;">
<td rowspan="15" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">General<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 294;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing Provider shall establish and maintain procedures to
control all documents that form part of its management system (internally
generated, or from external sources), such as regulations, standards, other
normative documents, proficiency scheme protocols, test or calibration
methods, or both test and calibration methods, as well as drawings, software
specifications, instructions and manuals. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 295;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Document
approval and issue<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 296;">
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">All
documents issued as part of the management system shall be reviewed and
approved for use by authorized personnel prior to issue. A master list or
equivalent documenter control procedure identifying the current revision
status and distribution of documents in the management system shall be
established and be readily available, in order to prevent the use of invalid
or obsolete documents, or both. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 297;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
procedures adopted shall also ensure that: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 298;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Authorized
editions of appropriate documents are available at all locations where
activities essential to the effective operation of Proficiency Testing
schemes are performed; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 299;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Documents
are periodically reviewed and updated, as necessary, to ensure continuing
suitability and compliance with applicable requirements; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 300;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Invalid
or obsolete documents are promptly removed from all points of issue or use,
or otherwise assured against unintended use; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 301;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Obsolete
documents retained for either legal or knowledge preservation purposes are
suitably marked. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 302;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Management
system documents generated by the Proficiency Testing provider shall be
uniquely identified. Such identification shall include the date of issue or
revision identification, or both, page numbering, the total number of pages
or a mark to signify the end of a document, and the issuing
authority/authorities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 303;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Document
Changes <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 304;">
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Changes
to documents shall be reviewed and approved by the same function that
performed the original review and approval, unless specifically designated
otherwise. The designated personnel shall have access to pertinent background
information upon which to base their review and approval. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 305;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
practicable, the altered or new text shall be identified in the document or
the appropriate attachment. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 306;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.3.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">If
the Proficiency Testing provider’s document control system allows for the
amendment of documents by hand, pending re–issue of the documents, the
procedures and authorities for such amendments shall be defined. Amendments
shall be clearly marked, initialled, and dated. A revised document shall be
issued as soon as practicable. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 307;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.3.3.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Procedures
shall be established to describe how changes in documents maintained in
computerized systems are made and controlled. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 308;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">REVIEW
OF REQUESTS, TENDERS AND CONTRACTS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 309;">
<td rowspan="10" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.4.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall establish and maintain policies and
procedures for the review of requests, tenders and contracts. These reviews
shall ensure that: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 310;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l23 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
requirements, including those for test and calibration methods, measuring
equipment and Proficiency Test items to be used, are adequately defined,
documented, and understood; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 311;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l23 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
Proficiency Testing provider has the capability and resources to meet the
requirements; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 312;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l23 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
Proficiency Testing scheme is technically appropriate. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 313;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
review is particularly important when a customer requests a Proficiency
Testing scheme to be created for a specific purpose or for a different level
or frequency of participation from that normally offered. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 314;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
review can be simplified when the Proficiency Test scheme is fully described
in a catalogue or other notice, and the participant is enrolling for a
routine shipment. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 315;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.4.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Records
of such reviews, including any changes, shall be maintained. Records shall
also be maintained of pertinent discussions with a customer relating to the
customer’s requirements, or the results of the work during the period of
execution of the contract, or both. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 316;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.4.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
review shall cover all aspects of the request, including any work that is
subcontracted by the Proficiency Testing Provider. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 317;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.4.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
participants and other customers, as appropriate, shall be informed of any
deviation in the contract or agreed Proficiency Testing scheme design. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 318;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.4.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">If
a request or contract is amended after the Proficiency Testing scheme is
underway, the same review process shall be repeated and any amendments shall
be communicated to all affected personnel. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 319;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.5<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">SUBCONTRACTING
SERVICES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 320;">
<td rowspan="7" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.5.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
a Proficiency Testing provider subcontracts work, the proficiency testing
provider shall demonstrate that the subcontractors experience and technical
competence are sufficient for their assigned tasks, and they comply with the
relevant clauses of this International Standard and other appropriate
standards. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 321;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.5.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing Provider shall not subcontract the planning of the
Proficiency Test Scheme (see 4.4.1.2), the evaluation of performance (see
4.7.2.1) or the authorization of the final report (see 4.8.1). <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 322;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
does not preclude the Proficiency Testing provider utilizing advice or
assistance from any advisors, experts or steering group. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 323;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.5.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing Provider shall inform participants, in advance and in
writing, of services that are, or maybe, subcontracted. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 324;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">This
notification can, for example, take the form of a statement in the
Proficiency Testing Scheme documentation such as the following: Various
aspects of the Proficiency Testing Scheme can from time to time be
subcontracted. When subcontracting occurs, it is placed with a competent
subcontractor and the proficiency testing provider is responsible for this
work.”<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 325;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.5.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall be responsible to the participants and
other customers for the subcontractor’s work, except in the case where a
regulatory authority specifies which subcontractor is to be used. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 326;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.5.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall maintain a register of all subcontractors
used in the operation of Proficiency Testing Schemes, including the scope of
subcontracting and a record of the competence assessment against relevant
parts of this International Standard and other appropriate standards for the
work in question. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 327;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.6<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">PURCHASING
SERVICES AND SUPPLIES<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 328;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.6.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall have a policy and procedure(s) for the
selection of services and supplies that it uses and that affect the quality
of its proficiency testing schemes. Procedures shall exist for the purchase,
reception and storage of reagents, proficiency test items, reference
materials and other consumable materials relevant for the Proficiency Testing
Schemes. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 329;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.6.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall ensure that purchased supplies, equipment
and consumable materials that affect the quality of proficiency testing
schemes are not used until they have been inspected or otherwise verified as
complying with specifications or requirements. Records of actions taken to
check compliance shall be maintained. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 330;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.6.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Purchasing
documents for items affecting the quality of Proficiency Testing schemes
shall contain data describing the services and supplies ordered. These
purchasing documents shall be reviewed and approved for technical content
prior to release. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 331;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.6.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall evaluate suppliers of critical supplies
and services which affect the quality of proficiency testing schemes. The
Proficiency Testing provider shall maintain records of these evaluations, and
list those suppliers that are approved. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 332;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.7<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">SERVICE
TO THE CUSTOMER<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 333;">
<td rowspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.7.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall be willing to cooperate with participants
and other customers in clarifying customer’s requests in monitoring the
proficiency testing provider’s performance in relation to the work performed,
provided that the Proficiency Testing provider assures confidentiality to its
participants. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 334;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.7.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall seek feedback, both positive and negative,
from its customers. The feedback shall be used and analysed to improve the
management system, proficiency testing schemes, and customer service. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 335;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Examples
of the types of feedback include customer satisfaction surveys and review of
Proficiency Testing reports with customers. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 336;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.8<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">COMPLAINTS
AND APPEALS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 337;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing providers shall have a policy and follow a procedure for
the resolution of complaints and appeals received from participants, customers,
or other parties. Records shall be maintained of all complaints, appeals,
investigations and corrective actions taken by the Proficiency Testing
provider. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 338;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" width="42">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.9<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">CONTROL
OF NONCONFORMING WORK<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 339;">
<td rowspan="8" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.9.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall have a policy and procedures(s) that shall
be implemented when any aspect of its activities does not conform to its own
procedures or the agreed requirements of its customers. The policy and
procedure(s) shall ensure that:<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="height: 81.45pt; mso-yfti-irow: 340;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 81.45pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting work of ongoing programmes and
withholding reports, as necessary) are defined and taken when nonconforming
work is identified; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 341;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">An
evaluation of the significance of the nonconforming work is made; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 342;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">A
decision on the need for action and timescale is taken immediately, together
with any decision about the acceptability of the nonconforming work; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 343;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Proficiency
Testing scheme participants and other customers, as appropriate, are informed
and the nonconforming proficiency test items or reports already sent to
participants are recalled or disregarded; and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 344;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
responsibility for authorization of the resumption of work is defined.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 345;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Identification
of nonconforming work or problems with the management system or with
technical activities can occur at various places within the management system
and technical operations. Examples are participant complaints, management
reviews and internal or external audits, quality control, preparations of
Proficiency Test items, homogeneity and stability tests, data analysis,
instructions to participants, and materials handling and storage. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 346;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.9.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
the evaluation indicates that nonconforming work could recur or that there is
doubt about the compliance of the Proficiency Testing provider or
subcontractor with their own policies and procedures, the corrective action
procedure in 5.11 shall be promptly followed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 347;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.10<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">IMPROVEMENT<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 348;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall continually improve the effectiveness of
its management system through the use of the quality policy, quality
objectives, audit results, analysis of data, corrective and preventive
actions and management review. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 349;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">CORRECTIVE
ACTION<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 350;">
<td rowspan="15" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">General<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 351;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall establish a policy and procedure(s) and
shall designate appropriate personnel for implementing corrective actions
when nonconforming work or departures from the policies and procedures in the
management system or technical operations have been identified. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 352;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Cause
Analysis<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 353;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
procedure for corrective action shall start with an investigation to
determine the root cause(s) of the problem.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 354;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Cause
analysis is the key and sometimes the most difficult part in the corrective
action procedure. Often, the root cause is not obvious and thus a careful
analysis of all potential causes of the problem is required. Potential causes
could include customer requirements, proficiency test items and their
specifications, methods and procedures, staff skills and training, consumable
supplies, preparations of Proficiency test items, homogeneity and stability
tests, statistical design, instructions to participants, and materials
handling and storage. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 355;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.3<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Selection
and implementation of corrective actions<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 356;">
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
corrective action is needed, the proficiency testing provider shall identify
potential corrective actions. It shall select and implement the action(s)
most likely to eliminate the problems and to prevent recurrence. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 357;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Corrective
actions shall be appropriate to the magnitude and risk of the problem. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 358;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.3.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency testing provider shall document and implement any required
changes resulting from corrective action investigations. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 359;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.3.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall document and implement any required
changes resulting from corrective action investigations. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 360;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.4<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Monitoring
of Corrective Actions<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 361;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall monitor the results to ensure that the corrective
actions taken have been effective. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 362;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.11.5<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Additional
audits <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 363;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
the identification of nonconforming activities or departures from authorized
procedures cast doubts on the compliance of the proficiency testing provider
with its own policies and procedures, or on its compliance with this
International Standard, the proficiency testing provider shall ensure that
the appropriate areas of activity are audited in accordance with 5.14 as soon
as possible. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 364;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Such
additional audits often follow the implementation of the corrective actions
to confirm their effectiveness. An additional audit can be necessary only
when a serious issue or risk to the Proficiency Testing scheme is identified.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 365;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.12<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">PREVENTIVE
ACTION<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 366;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.12.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Areas
for improvement and potential of nonconforming work, either technical or
concerning the management system, shall be identified. When improvement
opportunities are identified, or if preventive action is required, action
plans shall be developed, implemented and monitored, to reduce the likelihood
of such nonconforming work and to take advantage of the opportunities for
improvement. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 367;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.12.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Any
procedure for preventive action shall include the initiation of such actions
and application of controls to ensure that they are effective. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 368;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">CONTROL
OF RECORDS <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 369;">
<td rowspan="18" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.1<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">General<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 370;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall establish and maintain procedures for
identification, collection, indexing, access, filing, storage, maintenance,
and disposal of records. Quality records shall include reports from internal
audits and management reviews, as well as records or corrective and
preventive actions. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 371;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">All
records shall be legible and shall be stored and retained in such a way that
they are readily retrievable in facilities that provider a suitable
environment to prevent damage or deterioration and to prevent loss. Retention
times of records shall be established. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 372;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Records
can be in the form of any type of media, such as hard copy or electronic
storage media. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 373;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.1.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">All
records shall be kept secure and confidential, and in accordance with
relevant regulatory requirements. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 374;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.1.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
proficiency Testing provider shall follow procedures to protect and back–up
records stored electronically and to prevent unauthorized access or amendment
of these records. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 375;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.2<o:p></o:p></span></span></b></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Technical
Records <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 376;">
<td rowspan="11" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" valign="top" width="54">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall retain records of all technical data
relating to each Proficiency Testing round for a defined period, including
but not necessarily limited to: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 377;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l34 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Results
of homogeneity and stability testing; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 378;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l34 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Instructions
to participants; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 379;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l34 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Participants
original responses; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 380;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l34 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Collated
data for statistical analysis; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 381;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l34 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Information
required for reports (see 4.8); and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 382;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l34 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Final
reports (summary or individual, or both) <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 383;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
is advisable to retain sufficient information to establish an audit trail for
the processing of results from Proficiency Testing rounds<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 384;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Technical
records are accumulations of data and information which result from carrying
out all Proficiency Testing activities. They can include forms, contracts,
work sheets, work books, check sheets, work notes, subcontractor reports and
participant feedback. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 385;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Data
entry, checking and calculations shall be recorded at the time they are made
and shall be identifiable to the specific task and toe the personnel
responsible. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 386;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 49.8pt;" width="66">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.13.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 328.4pt;" valign="top" width="438">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
mistakes occur in records and alterations are made, actions shall be take to:
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Identify
the change and date of alteration; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Avoid
loss of original data; and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Identify
the person making the alteration<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 387;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.14<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">INTERNAL
AUDITS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 388;">
<td rowspan="5" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.14.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
Proficiency Testing provider shall conduct internal audits of its activities
periodically, and in accordance with a predetermined schedule, in order to
verify that is operation continue to comply with the requirements of the
management system and this International Standard. The internal audit
programme shall address all elements of the management system, including the
technical procedures and Proficiency Test item preparation, storage and
distribution, as well as reporting activities for the operation of
Proficiency Testing scheme. It is the responsibility of the Quality Manager
to plan and organize audits as required by the schedule and requested by
management. Internal audits shall be carried out by trained and qualified
personnel who are, wherever resources permit, independent of the activity to
be audited. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 389;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">It
is advisable that the programme for internal auditing of the management
system be completed every 12 months. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 390;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.14.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">When
audit findings cast doubt upon the effectiveness of the operations, including
the suitability and correctness of Proficiency Test items, procedures,
statistical evaluations and data presentation, the proficiency testing
provider shall take timely corrective action and shall notify its customers
or participants, or both, in Proficiency Testing schemes whose activities may
have been affected. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 391;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.14.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">The
area of audited activity, the audit findings and any corrective actions that
arise from them shall be recorded. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 392;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.14.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Follow–up
audit activities shall verify and record the implementation and effectiveness
of any corrective actions taken. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 393;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.15<o:p></o:p></span></span></b></p>
</td>
<td colspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 419.0pt;" valign="top" width="559">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">MANAGEMENT
REVIEWS<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 394;">
<td rowspan="16" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 31.8pt;" valign="top" width="42">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><o:p><span style="color: #01ffff; font-size: medium;"> </span></o:p></span></p>
</td>
<td rowspan="11" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.15.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">In
accordance with a pre–determined schedule and procedure, the Proficiency
Testing provider’s top management shall periodically conduct a review of the
Proficiency testing provider’s management system and Proficiency Testing
activities, in order to ensure their continued suitability and effectiveness
and to introduce any necessary changes or improvements. The review shall take
account of: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 395;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">a.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
suitability of policies and procedures; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 396;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">b.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Reports
from management and supervisory personnel; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 397;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">c.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">The
outcome of recent internal audits; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 398;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">d.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Corrective
and preventive actions; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 399;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">e.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Assessments
by external bodies; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 400;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">f.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Changes
in the volume and type of work; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 401;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">g.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Customer,
advisory group or participant feedback; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 402;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">h.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Complaints
and appeals; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 403;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">i.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Recommendations
for improvement; and<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 404;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff; font-size: medium;"><span style="font-family: "Palatino Linotype", serif;"><span style="mso-list: Ignore;">j.<span style="font-family: "Times New Roman"; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype", serif;">Other
relevant factors, such as resources and staff training. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 405;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A
typical period for conducting a management review is once every 12 months<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 406;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Results
can feed into the Proficiency Testing provider’s planning system and can
include the objectives and action plans. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 407;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">A
management review includes consideration of related subjects at regular
management meetings. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 408;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Note 4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Where
the Proficiency testing provider is part of a larger organization, it can be
appropriate to hold a separate review meeting to cover Proficiency Testing
activities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 409; mso-yfti-lastrow: yes;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 40.8pt;" width="54">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">5.15.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 378.2pt;" valign="top" width="504">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype", serif;"><span style="color: #01ffff; font-size: medium;">Findings
from management reviews, and the action that arise from them, shall be
recorded. The management shall ensure that those actions are discharged
within an appropriate and agreed timescale. <o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table>
</div>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0tag:blogger.com,1999:blog-1102712979345561714.post-58604514001775427742023-02-19T21:28:00.000+08:002023-02-19T21:28:39.761+08:00ISO 17011<p style="text-align: center;"><span style="color: #01ffff;"> <b style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;">CONFORMITY ASSESSMENT – GENERAL
REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING CONFORMITY ASSESSMENT BODIES</span></b></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
<div align="center">
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-yfti-tbllook: 1184;">
<tbody><tr style="mso-yfti-firstrow: yes; mso-yfti-irow: 0;">
<td colspan="3" style="border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">Scope</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">This
International Standard specifies general requirements for accreditation
bodies assessing and accrediting conformity assessment bodies (CABs). It is
also appropriate as a requirement document for the peer evaluation process
for mutual recognition arrangements between accreditation bodies. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Accreditation
bodies operating in accordance with this International Standard do not have
to offer accreditation to all types of CABs.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">For
the purposes of this International Standard, CABs are organizations providing
the following conformity assessment services: testing, inspection, management
system certification, personnel certification, product certification and, in
the context of this International Standard, calibration. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note:
General requirements for these bodies have been established, for example in
International Standards and Guides <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">Normative
Reference</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">ISO
9000: 2000, Quality Management Systems – Fundaments and Vocabulary <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">ISO/IEC
17000:2004, Conformity Assessment – Vocabulary and General Principles <o:p></o:p></span></span></p>
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">VIM:1993,
International vocabulary of basic and general terms in metrology, issued by
BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">Terms
and Definitions</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">For
the purposes of this document, the terms and definitions given in ISO/IEC
17000 and the following apply <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 10;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Accreditation</span></b><span style="font-family: "Palatino Linotype",serif;"> – third party attestation
related to conformity assessment body conveying formal demonstration of its
competence to carry out specific conformity assessment tasks <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 11;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Accreditation
body </span></b><span style="font-family: "Palatino Linotype",serif;">–
authoritative body that performs accreditation <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 12;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
authority of an accreditation body is generally derived from government.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 13;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Accreditation
body logo</span></b><span style="font-family: "Palatino Linotype",serif;"> –
logo used by an accreditation body to identify itself.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 14;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Accreditation
certificate</span></b><span style="font-family: "Palatino Linotype",serif;"> –
formal document or a set of documents, stating that accreditation has been
granted for the defined purpose. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 15;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Accreditation
symbol</span></b><span style="font-family: "Palatino Linotype",serif;"> –
symbol issued by an accreditation body to be used by accredited CABs to
indicate their accredited status. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 16;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">“Mark”
is to be reserved to indicate direct conformity of an entity against a set of
requirements. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 17;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Appeal</span></b><span style="font-family: "Palatino Linotype",serif;"> – request by a CAB for
reconsideration of any adverse decision made by the accreditation body relate
to its desired accreditation status. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 18;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Adverse
decisions include <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Refusal to
accept application <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Refusal to
proceed with an assessment, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Corrective
action requests, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Changes in
accreditation scope,<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Decision
to deny, suspend or withdraw accreditation, and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Any other
action that impedes the attainment of accreditation<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 19;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.7<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Assessment
</span></b><span style="font-family: "Palatino Linotype",serif;">– process
undertaken by an accreditation body to assess the competence of a CAB, based
on a particular standard(s) and/or other normative documents and for a
defined scope of accreditation<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 20;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Assessing
the competence of a CAB involves assessing the competence of the entire
operations of the CAB, including the competence of the personnel, the
validity of the conformity assessment methodology and the validity of the
conformity assessment results. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 21;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.8<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="tab-stops: 356.4pt;"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Assessor</span></b><span style="font-family: "Palatino Linotype",serif;">
– person assigned by an accreditation body to perform, alone or as part of an
assessment team, an assessment of CAB.<span style="mso-tab-count: 1;"> </span><o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 22;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.9<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Complaint
</span></b><span style="font-family: "Palatino Linotype",serif;">– expression
of dissatisfaction, other than appeal, by any person or organization, to an
accreditation body, relating to the activities of that accreditation body or
of an accredited CAB, where response is expected.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 23;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.10<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Conformity
Assessment Body (CAB)</span></b><span style="font-family: "Palatino Linotype",serif;">
– body that performs conformity assessment services and that can be the
object of accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 24;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Whenever
the word “CAB” is used in the text, it applies to both the “applicant and
accredited CABs” unless otherwise specified. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 25;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.11<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Consultancy</span></b><span style="font-family: "Palatino Linotype",serif;"> – participation in any
activities of a CAB subject to accreditation<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 26;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Examples:
<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Preparing
or producing manuals or procedures for a CAB; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Participating
in the operation or management of the system of a CAB;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Giving
specific advice or specific training towards the development and
implementation of the management system and/or competence of a CAB;<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l16 level1 lfo3; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;">–<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Giving
specific advice or specific training for the development and implementation
of the operational procedures of a CAB <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 27;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.12<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Expert
</span></b><span style="font-family: "Palatino Linotype",serif;">– person
assigned by an accreditation body to provide specific knowledge or expertise
with respect to the scope of accreditation to be assessed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 28;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.13<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Extending
accreditation</span></b><span style="font-family: "Palatino Linotype",serif;">
– process of enlarging the scope of accreditation <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 29;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.14<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Interested
parties</span></b><span style="font-family: "Palatino Linotype",serif;"> –
parties with a direct or indirect interest in accreditation <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 30;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Direct
interest refers to the interest of those who undergo accreditation; indirect
interest refers to the interests of those who use or rely on accredited
conformity assessment services <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 31;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.15<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Lead
assessor</span></b><span style="font-family: "Palatino Linotype",serif;"> –
assessor who is given the overall responsibility for specified assessment
activities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 32;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.16<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Reducing
Accreditation</span></b><span style="font-family: "Palatino Linotype",serif;">
– process of cancelling accreditation for part of the scope of accreditation <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 33;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.17<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Scope
of Accreditation</span></b><span style="font-family: "Palatino Linotype",serif;">
– specific conformity assessment services for which accreditation is sough or
has been granted. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 34;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.18<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Surveillance</span></b><span style="font-family: "Palatino Linotype",serif;"> – set of activities, except
reassessment, to monitor the continued fulfilment by accredited CABs of
requirements for accreditation<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 35;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Surveillance
includes both surveillance on–site assessments and other surveillance
activities, such as the following: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l23 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Enquiries from the accreditation body to the CAB
on aspects concerning the accreditation; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l23 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Reviewing the declarations of the CAB with respect
to what is covered by the accreditation; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l23 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Requests to the CAB to provide documents and
records (e.g. audit reports, results of internal quality control for
verifying the validity of CAB services, complaint records, management review
records); <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l23 level1 lfo4; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Monitoring the performance of the CAB (such as
results of participating in Proficiency Testing)<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 36;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.19<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Suspending
accreditation</span></b><span style="font-family: "Palatino Linotype",serif;">
– process of temporarily making accreditation invalid, in full or for part of
the scope of accreditation<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 37;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.20<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Withdrawing
accreditation</span></b><span style="font-family: "Palatino Linotype",serif;">
– process of cancelling accreditation in full. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 38;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">3.21<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif;">Witnessing</span></b><span style="font-family: "Palatino Linotype",serif;"> – observation of the CAB
carrying out conformity assessment services within its scope of
accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 39;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">Accreditation
Body</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 40;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall be a registered legal entity.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 41;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note:
Governmental accreditation bodies are deemed to be legal entities on the
basis of their governmental status. Where the governmental accreditation body
is part of a larger governmental entity, the government is responsible for
identifying the accreditation body in a way that no conflict of interest with
governmental CABs occur. This accreditation body is deemed to be the
“registered legal entity” in the context of this International Standard.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 42;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Structure<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 43;">
<td rowspan="9" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
structure and operation of an accreditation body shall be such as to give
confidence in its accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 44;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have authority and shall be responsible for its
decisions relating to accreditation, including the granting, maintaining,
extending, reducing, suspending, and withdrawing of accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 45;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have a description of its legal status, including
the names of its owners if applicable, and if different, the names of the
persons who control it. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 46;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall document the duties and responsibilities and
authorities of top management and other personnel associated with the
accreditation body who could affect the quality of the accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 47;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall identify the top management having overall authority
and responsibility for each of the following: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Development of policies relating to the operation
of the accreditation body; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Supervision of the implementation of the policies
and procedures; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Supervision of the finances of the accreditation
body; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Decisions on accreditation; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Contractual arrangements; <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l14 level1 lfo5; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Delegation of authority to committees or
individuals, as required, to undertake defined activities on behalf of top
management<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 48;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have access to necessary expertise for advising the
accreditation body on matters directly relating to accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 49;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Access
to the necessary expertise may be obtained through one or more advisory
committees (either ad–hoc or permanent), each responsible within its scope.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 50;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.7<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have formal rules for the appointment, terms of
reference and operation of committees that are involved in the accreditation
process and shall identify the parties participating. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 51;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.2.8<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall document its entire structure, showing lines of
authority and responsibility <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 52;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Impartiality
<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 53;">
<td rowspan="14" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall be organized and operated so as to safeguard the
objectivity and impartiality of its activities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 54;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">For
safeguarding impartiality and for developing and maintaining the principles
and major policies of operation of its accreditation system, the
accreditation body shall have documented and implemented a structure to
provide opportunity for effective involvement by interested parties. The
accreditation body shall ensure a balanced representation of interested
parties with no single party predominating. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 55;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body’s policies and procedures shall be non– discriminatory and
shall be administered in a non–discriminatory way. The accreditation body
shall make its services accessible to all applicants whose requests for
accreditation fall within the activities (see 4.6.1) and the limitations as
defined within its policies and rules. Access shall not be conditional upon
the size of the applicant CAB or membership of any association or group, nor
shall accreditation be conditional upon the number of CABs already
accredited. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 56;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">All
accreditation body personnel and committees that could influence the
accreditation process shall act objectively and shall be free from any undue
commercial, financial, and other pressures that could compromise
impartiality. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 57;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body personnel and committees that could influence the
accreditation process shall act objectively and shall be free from any undue
commercial, financial and other pressures that could compromise impartiality.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 58;">
<td rowspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3.6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall not offer or provide any service that affects its
impartiality, such as <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l27 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Those conformity assessment services that CABs
perform, or<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l27 level1 lfo6; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Consultancy <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 59;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body’s activities shall not be presented as linked with
consultancy. Nothing shall be said or implied that would suggest that
accreditation would be simpler, easier, faster or less expensive if any
specified person(s) or consultancy were used. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 60;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.3.7<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure that the activities of its related bodies do
not compromise the confidentiality, objectivity and impartiality of its
accreditations. A related body may, however, offer consultancy or provide
those conformity assessment services the accreditation body accredits,
subject to the related body having (with respect to the accreditation body).<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 61;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">different top management for the activities
described in 4.2.5<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 62;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">personnel different from those involved in the
decision–making processes of accreditation <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 63;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">no possibility to influence the outcome of an
assessment for accreditation, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 64;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l35 level1 lfo8; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">distinctly different name, logos and symbols.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 65;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note 1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">A
related body is a separate legal entity that is linked by common ownership or
contractual arrangements to the accreditation body as described in 4.1<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 66;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note 2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">A
separate part of the government, outside the governmental accreditation body
as described in 4.1, is considered as a related body<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 67;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Confidentiality
<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 68;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have adequate arrangements to safeguard the
confidentiality of the information obtained in the process of its
accreditation activities at all levels of the accreditation body, including committees
and external bodies or individuals acting on its behalf. The accreditation
body shall not disclose confidential information about a particular CAB
outside the accreditation body without written consent of the CAB, except
where the law requires such information to be disclosed without such consent <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 69;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Liability
and Financing<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 70;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.5.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have arrangement to cover liabilities arising from
its activities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 71;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.5.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have the financial resources, demonstrated by
records, and/or documents, required for the operation of its activities. The
accreditation body shall have a description of its source(s) of income.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 72;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Accreditation
Activity <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 73;">
<td rowspan="8" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.6.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall clearly describe its accreditation activities,
referring to the relevant International Standards, Guides and other normative
documents. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 74;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.6.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body may adopt application or guidance documents and/or
participate in the development of them. The accreditation body shall ensure
that such documents have been formulated by committees or persons possessing
the necessary competence and, where appropriate, with participation of
interested parties. Where international application or guidance documents are
available, these should be used. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 75;">
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">4.6.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for extending its activities
and to react to demands of interested parties. Possible elements to be
included in the procedures are:<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 76;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">analysis of its present competence, suitability of
extension, resources, etc. in the new field, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 77;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">accessing and employing expertise from other
external sources, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 78;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">evaluating the need for application or guidance
documents, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 79;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">initial selection and training of assessors, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 80;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l2 level1 lfo10; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">training accreditation body’s staff in the new
field. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 81;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">Management</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 82;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">General<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 83;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish, implement and maintain a management
system and continually improve its effectiveness in accordance with the
requirements of this International Standard. Requirements for the management
system that take into account the particular nature of accreditation bodies
are defined in 5.2 to 5.9.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 84;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Where
this International Standard requires the accreditation body to have or
established procedures, this means that they shall be documented, implemented
and shall be based on formulated policies wherever suitable.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 85;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Management
System <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 86;">
<td rowspan="6" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body’s top management shall define and document policies and
objectives, including a quality policy, for its activities, and it shall
provide evidence of commitment to quality and to compliance with the
requirements of this International Standard. The management shall ensure
effective communication of the needs of interested parties. The management
shall also ensure that the policies are understood, implemented, and
maintained at all levels of the accreditation body. The objectives should be
measurable and shall be consistent with the accreditation body’s policies. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 87;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Those
accreditation bodies that the signatories to a mutual recognition arrangement
may refer to the obligations of the mutual recognition arrangement in their
policies. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 88;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall operate a management system appropriate to the type,
range and volume of work performed. All applicable requirements of this
International Standard shall be addressed either in a manual or in associated
documents. The accreditation body shall ensure that the manual and relevant
associated documents are accessible to its personnel and shall ensure
effective implementation of the system’s procedures. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 89;">
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body’s top management shall appoint a member who, irrespective
of other responsibilities, shall have responsibility and authority that
includes,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 90;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Ensuring that procedures needed for the management
system are established, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 91;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l3 level1 lfo11; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Reporting to top management on the performance of
the management system and any need for improvement <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 92;">
<td rowspan="8" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures to control all documents
(internal and external) that relate to its accreditation activities. The procedures
shall define the controls needed<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 93;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">To approve
documents for adequacy prior to issue, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 94;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">To review
and update as necessary and re – approve documents, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 95;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">To ensure
that changes and the current revision status of documents are identified. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 96;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">To ensure
that relevant versions of applicable documents are available to personnel,
subcontractors, assessors and experts of the accreditation body and CABs at
points of use, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 97;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">To ensure
that documents remain legible and readily identifiable, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 98;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">To prevent
the unintended use of obsolete documents and to apply suitable identification
to them if they are retained for any purpose, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 99;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l28 level1 lfo12; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">To
safeguard, where relevant, the confidentiality of documents. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 100;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Records
<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 101;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.4.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for identification, collection,
indexing, accessing, filing, storage, maintenance, and disposal of its
records. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 102;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.4.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation shall establish procedures for retaining records for a period
consistent with its contractual and legal obligations. Access to these
records shall be consistent with the confidentiality arrangements. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 103;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Nonconformities
and Corrective Actions<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 104;">
<td rowspan="8" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for the identification and
management of nonconformities in its own operations. The accreditation body
shall also, where necessary, take actions to eliminate the causes of
nonconformities in order to prevent recurrence. Corrective actions shall be
appropriate to the impact of the problems encountered. The procedures shall
cover the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 105;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l15 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">identifying
nonconformities (e.g. from complaints and internal audits); <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 106;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l15 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">determining
the causes of nonconformity; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 107;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l15 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">correcting
nonconformities; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 108;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l15 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">evaluating
the need for actions to ensure that nonconformities do not recur; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 109;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l15 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">determining
the actions needed and implementing them in a timely manner; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 110;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l15 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">recording
the results of actions taken; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 111;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l15 level1 lfo14; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">reviewing
the effectiveness of corrective actions<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 112;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Preventive
Actions <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 113;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l44 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">identifying
potential nonconformities and their causes, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 114;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l44 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">determining
and implementing the preventive actions needed, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 115;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l44 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">recording
results of actions taken, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 116;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l44 level1 lfo15; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">reviewing
the effectiveness of the preventive actions taken <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 117;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.7<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Internal
Audits <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 118;">
<td rowspan="9" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.7.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for internal audits to verify
that they conform to the requirements of this International Standard and that
the management system is implemented and maintained. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 119;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">As
an indication, ISO 19011 provides guidelines for conducting internal audits.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 120;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.7.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Internal
audits shall be performed normally at least once a year. The frequency of
internal audits may be reduced if the accreditation body can demonstrate that
its management system has been effectively implemented according to this
International Standard and has proven stability. An audit programme shall be
planned, taking into consideration the importance of the processes and areas
to be audited, as well as the results of previous audits. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 121;">
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.7.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure that <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 122;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Internal audits are conducted by qualified
personnel knowledgeable in accreditation, auditing and the requirements of
this International Standard, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 123;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Internal audits are conducted by personnel
different from those who perform the activity to be audited, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 124;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Personnel responsible for the area audited are
informed of the outcome of the audit,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 125;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Actions are taken in a timely and appropriate
manner, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 126;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l6 level1 lfo16; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Any opportunities for improvement are identified <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 127;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.8<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Management
Reviews <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 128;">
<td rowspan="19" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.8.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body’s top management shall establish procedures to review its
management system at planned intervals to ensure its continuing adequacy and
effectiveness in satisfying the relevant requirements, including this
International Standard and the stated polies and objectives. These reviews
should be conducted normally at least once a year. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 129;">
<td rowspan="13" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.8.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Inputs
to management reviews shall include, where available, current performance and
improvement opportunities to the following:<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 130;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Results of
audits; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 131;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Results of
peer evaluation where relevant; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 132;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Participation
in international activities, where relevant; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 133;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Feedback
from interested parties; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 134;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">New areas
of accreditation <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 135;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Trends in
nonconformities <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 136;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Status of
preventive and corrective actions; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 137;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">h.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Follow –
up actions from earlier management reviews <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 138;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">i.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Fulfilment
of objectives <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 139;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">j.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Changes
that cold affect the management system; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 140;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">k.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Appeals <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 141;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l38 level1 lfo17; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">l.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Analysis
of complaints <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 142;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.8.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
outputs from the management system and its processes; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 143;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Improvement of the management system and its
processes,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 144;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Improvement of services and accreditation process
in conformity with the relevant standards and expectations of interested parties,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 145;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Need for resources, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 146;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l8 level1 lfo18; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Defining or redefining of policies, goals and
objectives <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 147;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">5.9<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Complaints
<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 148;">
<td rowspan="6" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for dealing with complaints.
The accreditation body<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 149;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
decide on the validity of the complaint, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 150;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall,
where appropriate, ensure that a complaint concerning an accredited CAB is
first addressed by the CAB, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 151;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall take
appropriate actions and assess their effectiveness,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 152;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
record all complaints and actions taken, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 153;">
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l13 level1 lfo19; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
respond to the complainant<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 154;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">6.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">Human
Resources</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 155;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Personnel
associated with the accreditation body <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 156;">
<td rowspan="4" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have a sufficient number of competent personnel
(internal, external, temporary, or permanent, full time or part time) having
the education, training, technical knowledge, skills and experience necessary
for handling the type, range and volume of work performed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 157;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall have access to a sufficient number of assessors,
including lead assessors, and experts to cover all its activities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 158;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.1.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall make clear to each person concerned the extent and
the limits of their duties, responsibilities, and authorities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 159;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.1.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall require all personnel to commit themselves formally
by a signature or equivalent to comply with the rules defined by the
accreditation body. The commitment shall consider aspects relating to
confidentiality and to independence from commercial and other interests, and
any existing or prior association with CABs to be assessed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 160;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Personnel
involved in the accreditation process <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 161;">
<td rowspan="12" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall describe for each activity involved in the
accreditation process<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 162;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l29 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The
qualifications, experience, and competence required, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 163;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l29 level1 lfo20; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Initial
and ongoing training required<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 164;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for selecting, training and
formally approving assessors and experts used in the assessment process.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 165;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall identify the specific scopes in which each assessor
and expert has demonstrated competence to assess. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 166;">
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.2.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure that assessors and, where relevant, experts<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 167;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Are
familiar with accreditation procedures, accreditation criteria and other
relevant requirements, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 168;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Have
undergone a relevant accreditation assessor training, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 169;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Have a
thorough knowledge of the relevant assessment methods, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 170;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Are able
to communicate effectively, both in writing and orally, in the required
languages, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 171;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l10 level1 lfo21; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Have
appropriate personal attributes <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 172;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Guidance
on personal attributes may be found in publications such as ISO 19011<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 173;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Monitoring<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 174;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure the satisfactory performance of the
assessment and the accreditation decision–making process by establishing
procedures for monitoring the performance and competence of the personnel
involved. In particular, the accreditation body shall review the performance
and competence of its personnel in order to identify training needs. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 175;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall conduct monitoring (e.g. by on–site observations, or
by using other techniques such as review of assessment reports, feedback from
CABs and peer monitoring of assessors) to evaluate an assessor’s performance
and to recommend appropriate follow–up actions to improve performance. Each
assessor shall be observed on–site regularly, normally every three years,
unless there is sufficient supporting evidence that the assessor is
continuing to perform competently.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 176;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Personnel
Records<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 177;">
<td rowspan="9" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.4.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall maintain records of relevant qualifications,
training, experience and competence of each person involved in the
accreditation process. Records of training, experience and monitoring shall
be kept up to date. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 178;">
<td rowspan="8" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">6.4.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall maintain up–to–date records on assessors and experts
consisting of at least the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 179;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Name and
address; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 180;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Position
held and for external assessors and experts, the position held in their own
organization; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 181;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Educational
qualifications and professional status; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 182;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Work
experience; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 183;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Training
in management systems, assessment, and conformity assessment activities; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 184;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Competence
for specific assessment tasks; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 185;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l32 level1 lfo22; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Experience
in assessment and results of their regular monitoring<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 186;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" valign="top" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">7.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 14.0pt;">Accreditation
Process</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 187;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Accreditation
Criteria and Information<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 188;">
<td rowspan="13" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
general criteria for accreditation of CABs shall be those set out in the
relevant normative documents such as International Standards and Guides for
the operation of CABs<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 189;">
<td rowspan="11" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall make publicly available, and update at adequate
intervals, the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 190;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Detailed
information about its assessment and accreditation process, including
arrangements for granting, maintaining, extending, reducing, suspending, and
withdrawing accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 191;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A document
or reference documents containing the requirements for accreditation,
including technical requirements specific to each field of accreditation,
where applicable; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 192;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">General
information about the fees relating to the accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 193;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A
description of the rights and obligations of CABs<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 194;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Information
on the accredited CABs as described in 8.2.1<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 195;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Information
on procedures for lodging and handling complaints and appeals; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 196;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Information
about the authority under which the accreditation programme operates; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 197;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">h.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A
description of its rights and duties; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 198;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">i.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">General
information about the means by which it obtains financial support; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 199;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">j.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Information
about its activities and stated limitations under which it operates; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 200;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" valign="top" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l18 level1 lfo23; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">k.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Information
about the related bodies as described in 4.3.7, if applicable<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 201;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Application
for Accreditation<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 202;">
<td rowspan="9" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall require a duly authorized representative of the
applicant CAB to make a formal application that includes the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 203;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l45 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">General
features of the CAB, including corporate entity, name, address, legal status
and human and technical resources; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 204;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l45 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">General
information concerning the CAB such as its activities, its relationship in a
larger corporate entity if any, and addresses of all its physical location(s)
to be covered by the scope of accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 205;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l45 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A clearly
defined, requested, scope of accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 206;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l45 level1 lfo24; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">An
agreement to fulfil the requirements for accreditation and other obligations
of the CAB, as described in 8.1<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 207;">
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall require the applicant CAB to provide at least the
following information relevant to the accreditation prior to commencement of
the assessment: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 208;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A description of the conformity assessment
services that the CAB undertakes, and a list of standards, methods or
procedures for which CAB seeks accreditation, including limits of capability
where applicable; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 209;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l0 level1 lfo25; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A copy (on paper or in electronic form) of the
quality manual of the CAB, and relevant associated documents and records,
such as information as described in 7.15, where applicable.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 210;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall review for adequacy the information supplied by the
CAB<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 211;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Resource
Review<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 212;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall review its ability to carry out the assessment of
the applicant CAB, in terms of its own policy, its competence and the
availability of suitable assessors and experts. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 213;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
review shall also include the ability of the accreditation body to carry out
the initial assessment in a timely manner. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 214;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.4<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Subcontracting
the Assessment <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 215;">
<td rowspan="8" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.4.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall normally undertake the assessment on which
accreditation is based. The accreditation body shall not subtract the
decision–making. If the accreditation body subcontracts assessments, it shall
have a policy describing the conditions under which subcontracting may take
place. A properly documented agreement covering the arrangements, including
confidentiality and conflict of interest, shall be draw up. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 216;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Contracting
of external individual assessors and experts is not to be considered as
subcontracting<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 217;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.4.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 218;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l40 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall take
full responsibility for all subcontracted assessments and shall itself have
competence in the decision–making,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 219;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l40 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
maintain its responsibility for granting, maintaining, extending, reducing,
suspending, or withdrawing accreditation, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 220;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l40 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
ensure that the body and its personnel involved in the assessment process, to
which assessment has been subcontracted, are competent and comply with the
applicable requirements of this International Standard and any provisions and
guidelines given by the subcontracting accreditation body, and<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 221;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l40 level1 lfo26; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">shall
obtain the written consent of the CAB to use a particular subcontractor. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 222;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.4.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall list the subcontractors it uses for assessments and
shall have means for assessing and monitoring their competence and for
recording the results. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 223;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Preparation
of Assessment <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 224;">
<td rowspan="14" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Before
the initial assessment, a preliminary visit may be conducted with the
agreement of the CAB. This visit may result in identification of deficiencies
in the system of the applicant CAB or its competencies. The accreditation
body shall have clear rules and shall exercise due care to avoid consultancy
during such activities.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 225;">
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall formally appoint an assessment team consisting of a
lead assessor and, where required, a suitable number of assessors and/or
experts for each specific scope. When selecting the assessment team, the
accreditation body shall ensure that the expertise brought to each assignment
is appropriate. In particular, the team as a whole<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 226;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l17 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">shall have
appropriate knowledge of the specific scope for which accreditation is sough,
and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 227;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l17 level1 lfo28; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">shall have
understanding sufficient to make a reliable assessment of the competencies of
the CAB to operate within its scope of accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 228;">
<td rowspan="3" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure that team members act in an impartial and
non–discriminatory manner. In particular, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 229;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l42 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">assessment
team members shall not have provided consultancy to the CAB which might
compromise the accreditation process and decision, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 230;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l42 level1 lfo29; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">in
accordance with the provisions of 6.1.4, the assessment team members shall
inform the accreditation body, prior to the assessment, about any existing,
former, or envisaged link or competitive position between themselves or their
organization and the CAB to be assessed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 231;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall inform the CAB of the names of the members of the
assessment team and the organization they belong to, sufficiently in advance
to allow the CAB to object to the appointment of any particular assessor or
expert. The accreditation body shall have a policy for dealing with such
objections. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 232;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall clearly define the assignment given to the
assessment team. The task of the assessment team is to review the documents
collected from the CAB and to conduct the on–site assessment. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 233;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for sampling (if applicable)
where the scope of the CAB covers a variety of specific conformity assessment
services. The procedures shall ensure that the assessment team witness a
representative number of examples to ensure proper evaluation of the
competence of the CAB<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 234;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.7<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">For
initial assessments, in addition to visiting the main or head office, visits
shall be made to all other premises of the CAB from which one or ore key
activities are performed and which are covered by the scope of accreditation.
<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 235;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.8<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">For
surveillance and reassessment, where the CAB works from various premises, the
accreditation body shall establish procedures for sampling to ensure proper assessment.
All premises from which one or more key activities are performed should be
assessed within a defined timeframe.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 236;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.9<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall agree, together with the CAB and the assigned
assessment to the date and schedule for the assessment. However, it remains
the responsibility of the accreditation body to pursue a date that is in
accordance with the surveillance and reassessment plan. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 237;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.5.10<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure that the assessment team is provided with the
appropriate criteria documents, previous assessment records, and the relevant
documents and records of the CAB.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 238;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.6<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Document
and Record Review <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 239;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.6.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
assessment team shall review all relevant documents and records supplied by
the CAB (as described in 7.2.1 and 7.2.2) to evaluate its system, as
documented, for conformity with the relevant standard(s) and other
requirements for accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 240;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.6.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body may decide not to proceed with an on–site assessment based
on the nonconformities found during document and record review. In such
cases, the nonconformities shall be reported in writing to the CAB. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 241;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.7<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">On–site
Assessment <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 242;">
<td rowspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.7.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
assessment team shall commence on the on–site assessment with an opening
meeting at which the purpose of the assessment and accreditation criteria are
clearly defined, and the assessment schedule as well as the scope for the
assessment are confirmed. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 243;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.7.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
assessment team shall conduct the assessment of the conformity assessment
services of the CAB at the premises of the CAB from which one or more key
activities are performed and, where relevant, shall perform witnessing at
other selected locations where the CAB operates, to gather objective evidence
that the applicable scope the CAB is competent and conforms to the relevant
standard(s) and other requirements for accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 244;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.7.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
assessment team shall witness the performance of a representative number of
staff of the CAB to provide assurance of the competence of the CAB across the
scope of accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 245;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.8<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Analysis
of Findings and Assessment Report<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 246;">
<td rowspan="20" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.8.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
assessment team shall analyse all relevant information and evidence gathered
during the document and record review and the on – site assessment. This
analysis shall be sufficient to allow the team to determine the extent of
competence and conformity of the CAB with the requirements for accreditation.
The team’s observations on areas for possible improvement may also be
presented to the CAB. However, consultancy shall not be provided. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 247;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.8.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Where
the assessment team cannot reach a conclusion about a finding, the team
should refer back to the accreditation body for clarification.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 248;">
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.8.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body’s reporting procedures shall ensure that the following
requirements are fulfilled.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 249;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l39 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A meeting
shall take place between the assessment team and the CAB prior to leaving the
site. At this meeting, the assessment team shall provide a written and/or
oral report on its findings obtained from the analysis (see 7.8.1). An
opportunity shall be provided for the CAB to ask questions about the
findings, including nonconformities, if any, and their basis. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 250;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l39 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A written
report on the outcome of the assessment shall be promptly brought to the
attention of the CAB. This assessment report shall contain comments on
competence and conformity, and shall identify nonconformities, if any, to be
resolved in order to conform with all of the requirements for accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 251;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l39 level1 lfo30; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB
shall be invited to respond to the assessment report and to describe the
specific actions taken or planned to be taken, within a defined time, to
resolve any identified nonconformities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 252;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.8.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall remain responsible for the content of the assessment
report, including nonconformities, even if the lead assessor is not a
permanent staff member of the accreditation body. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 253;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.8.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure that the responses of the CAB to resolve
nonconformities are reviewed to se if the actions appear to be sufficient and
effective. If the CAB responses are found not to be sufficient, further
information shall be requested. Additionally, evidence of effective
implementation of actions taken may be requested, or a follow–up assessment
may be carried out to verify effective implementation of corrective actions. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 254;">
<td rowspan="12" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.8.6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
information provided to the accreditation decision – maker(s) shall include
the following, as a minimum:<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 255;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Unique identification of the CAB;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 256;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Date(s) of the on–site assessment; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 257;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Name(s) of the assessor(s) and/or experts involved
in the assessment; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 258;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Unique identification of all premises assessed; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 259;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Proposed scope of accreditation that was
assessed;; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 260;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A statement of the adequacy of the internal
organization and procedures adopted by the CAB to give confidence in its
competence, as determined through its fulfilment of the requirements for
accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 261;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A statement on the adequacy of the internal organization
and procedures adopted by the CAB to give confidence in its competence, as
determined through its fulfilment of the requirements for accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 262;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">h.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Information on the resolution of all
nonconformities<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 263;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">i.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Any further information that may assist in
determining fulfilment and the competence of the CAB;<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 264;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">j.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Where applicable, a summary of the results of
Proficiency Testing or other comparison conducted by the CAB and any actions
taken as consequence of the results; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 265;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l9 level1 lfo31; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">k.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Where appropriate, a recommendation as to
granting, reducing or extending accreditation for the proposed scope. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 266;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.9<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Decision–making
and Granting Accreditation<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 267;">
<td rowspan="16" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.9.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall, prior to making a decision, be satisfied that the
information (see 7.8.6) is adequate to decide that the requirements for
accreditation have been fulfilled. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 268;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.9.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall, without undue delay, make the decision on whether
to grant or extend accreditation on the basis of an evaluation of all
information received (see 7.8.6) and any other relevant information. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 269;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.9.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Where
the accreditation body uses the results of an assessment already performed by
another accreditation body, it shall have assurance that the other
accreditation was operating in accordance with the requirements of this
International Standard. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 270;">
<td rowspan="8" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.9.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall provide an accreditation certificate to the
accredited CAB. This accreditation certificate shall identify (on the front
page, if possible) the following:<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 271;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l37 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The
identity and logo of the accreditation body; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 272;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l37 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The unique
identity of the accredited CAB; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 273;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l37 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">All
premises from which one or more key activities are performed and which are
covered by the accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 274;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l37 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The unique
accreditation number of the accredited CAB; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 275;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l37 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The
effective date of granting of accreditation and, as applicable, the expiry
date; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 276;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l37 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A brief
indication of, or reference to, the scope of accreditation; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 277;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l37 level1 lfo32; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">A
statement of conformity and a reference to the standard(s) or other normative
document(s), including issue or revision used for assessment of the CAB.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 278;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.9.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation certificate shall also identify the following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 279;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">For certification bodies:<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l24 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The type
of certification, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l24 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The
standards or normative documents, or regulatory requirements or types
thereof, to which products, personnel, services or management systems are
certified, as applicable, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l24 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Industry
sectors, where relevant, <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l24 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">4.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Product
categories, where relevant, and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l24 level1 lfo34; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">5.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Personnel
categories, where relevant; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 280;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">For inspection bodies: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l21 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The type
of inspection body (e.g. as defined in ISO/IEC 17020),<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l21 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">2.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The field
and range of inspection for which accreditation has been granted, and <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l21 level1 lfo35; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">3.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The
regulations, standards or specifications or types thereof containing the
requirements against which the inspection is to be performed, as applicable; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 281;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">For calibration laboratories:<o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l5 level1 lfo36; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The calibrations, including the types of
measurements performed, the measurement ranges and the best measurement
capability (BMC) or equivalent; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 282;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l1 level1 lfo33; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">For testing laboratories: <o:p></o:p></span></span></p>
<p class="MsoNoSpacing" style="margin-left: 36.0pt; mso-list: l20 level1 lfo37; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">1.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The test
or types of tests performed and materials or products tested and, where
appropriate, the methods used. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 283;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.10<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Appeals<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 284;">
<td rowspan="7" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.10.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures to address appeals by CABs.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 285;">
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.10.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 286;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l26 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
appoint a person, or group or person, to investigate the appeal who are
competent and independent of the subject of the appeal, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 287;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l26 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
decide on the validity of the appeal, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 288;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l26 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall
advise the CAB of the final decision(s) of the accreditation body,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 289;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l26 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall take
follow–up action where required, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 290;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l26 level1 lfo38; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Shall keep
records of all appeals, of final decisions, and of follow–up taken<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 291;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Reassessment
and Surveillance<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 292;">
<td rowspan="12" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Reassessment
is similar to an initial assessment as described in 7.5 to 7.9, except that
experience gained during previous assessment shall be taken into account.
Surveillance on–site assessments are less comprehensive than reassessments. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 293;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
Accreditation body shall establish procedures and plans for carrying out
periodic surveillance on–site assessments, or other surveillance activities
and reassessments at sufficiently close intervals to monitor the continued
fulfilment by the accredited CAB of the requirements for accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 294;">
<td rowspan="6" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall design its plan for reassessment and surveillance of
each accredited CAB so that representative samples of the scope of
accreditation are assessed on a regular basis.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 295;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
interval between on–site assessments, whether reassessment or surveillance,
depends on the proven stability that the services of the CAB have reached.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 296;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Accreditation
bodies shall rely on either reassessment alone or a combination or
reassessment and surveillance, as follows: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 297;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">If based
on reassessment alone, then the reassessment shall take place at intervals
not exceeding 2 years; or <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 298;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l11 level1 lfo39; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">If the
combination of reassessment and surveillance is relied upon, then the
accreditation body shall undertake a reassessment at least every 5 years.
However, the interval between the surveillance on – site assessments should
not exceed 2 years. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 299;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">It
is, however, recommended that the first surveillance on–site assessment be
carried out no later than 12 months from the date of initial accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 300;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" valign="top" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Surveillance
on–site assessments shall be planned taking into account other surveillance
activities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 301;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" valign="top" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11.5<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">When,
during surveillance or reassessments, nonconformities are identified, the
accreditation body shall define strict time limits for corrective actions to
be implemented. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 302;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" valign="top" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11.6<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall confirm the continuation of accreditation, or decide
on the renewal of accreditation, based on the results of surveillance and
reassessments described above. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 303;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" valign="top" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.11.7<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body may conduct extraordinary assessments as a result of
complaints or changes (see 8.1.2), etc. The accreditation body shall advise
CABs of this possibility. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 304;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.12<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Extending
Accreditation <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 305;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall, in response to an application for an extension of
scope of an accreditation already granted, undertake the necessary activities
to determine whether or not the extension may be granted. Where appropriate,
assessment and granting procedures shall be as in defined in 7.5 to 7.9.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 306;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.13<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Suspending,
Withdrawing or Reducing accreditation <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 307;">
<td rowspan="6" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.13.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures for the suspension, withdrawal
or reduction of the scope of accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 308;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Depending
on the type of conformity assessment, the rules set by the accreditation body
may differ. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 309;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.13.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall make decisions to suspend and/or withdraw
accreditation when an accredited CAB has persistently failed to meet the
requirements of accreditation or to abide by the rules for accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 310;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
CAB may ask for suspension or withdrawal of accreditation <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 311;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.13.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall make decisions to reduce the scope of accreditation
of the Cab to exclude parts where the CAB has persistently failed to meet the
requirements for accreditation, including competence. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 312;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
CAB may ask for reduction of its scope of accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 313;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.14<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Records
on CABs<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 314;">
<td rowspan="7" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.14.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall maintain records on CABs to demonstrate that
requirements for accreditation, including competence, have been effectively
fulfilled. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 315;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.14.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall keep the records on CABs secure to ensure
confidentiality. The records on CABs shall be managed appropriately in a
manner as described in 5.4.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 316;">
<td rowspan="5" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.14.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Records
on CABs shall include <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 317;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Relevant correspondence, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 318;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Assessment records and reports <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 319;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Records of committee deliberations, if applicable,
and accreditation decisions, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 320;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l4 level1 lfo40; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Copies of accreditation certificates<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 321;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.15<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Proficiency
Testing and other comparisons for Laboratories <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 322;">
<td rowspan="6" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.15.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall establish procedures to take into account, during
the assessment and the decision–making process, the laboratory’s
participation and performance in Proficiency Testing.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 323;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.15.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body may organize Proficiency Testing or other comparisons
itself, or may involve another body judged to be competent. The accreditation
body shall maintain a list of appropriate Proficiency Testing and other
comparison programmes. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 324;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Guidelines
on operation and selection of Proficiency Testing and related definitions
exist in ISO/IEC Guide 43 – 1 and ISO/IEC Guide 43 – 2.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 325;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">7.15.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall ensure that its accredited laboratories participate
in Proficiency Testing or other comparison programmes, where available and
appropriate, and that corrective actions are carried out when necessary. The
minimum amount of Proficiency Testing and the frequency of participation
shall be specified in cooperation with interested parties and shall be
appropriate in relation to other surveillance activities. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 326;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note 1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">It
is recognized that there are particular areas where Proficiency Testing is
impractical. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 327;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note 2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Proficiency
Testing may also be used in many types of inspection. Clause 7.15 should be
read in this sense. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 328;">
<td colspan="3" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 450.8pt;" width="601">
<p align="center" class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l43 level1 lfo2; text-align: center; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><b><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">8.<span style="font: 7.0pt "Times New Roman";"> </span></span></span></b><!--[endif]--><span dir="LTR"></span><b><span style="font-family: "Palatino Linotype",serif; font-size: 12.0pt;">Responsibilities
of the Accreditation Body and the CAB</span></b><b><span style="font-family: "Palatino Linotype",serif;"><o:p></o:p></span></b></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 329;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.1<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" valign="top" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Obligations
of the CAB<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 330;">
<td rowspan="16" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td rowspan="9" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.1.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall require the CAB to conform to the following<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 331;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB shall commit to fulfil continually the
requirements for accreditation set by the accreditation body for the areas
where accreditation is sought or granted. This includes agreement to adapt to
changes in the requirements for accreditation, as set out in 8.2.4.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 332;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">When requested, the CAB shall afford such accommodation
and cooperation as is necessary to enable the accreditation body to verify
fulfilment of requirements for accreditation. This applies to all premises
where the conformity assessment services take place.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 333;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB shall provide access to information,
documents, and records as necessary for the assessment and maintenance of the
accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 334;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB shall provide access to those documents
that provide insight into the level of independence and impartiality of the
CAB from its related bodies, where applicable.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 335;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB shall arrange the witnessing of CAB
services when requested by the accreditation body.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 336;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB shall claim accreditation only with
respect to the scope for which it has been granted accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 337;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">g.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB shall not use its accreditation in such a
manner as to bring the accreditation body into disrepute.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 338;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l7 level1 lfo45; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">h.<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The CAB shall pay fees as shall be determined by
the accreditation body.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 339;">
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.1.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall require that it is informed by the accredited CAB,
without delay, of significant changes relevant to its accreditation, in any
aspect of its status or operation relating to<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 340;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo46; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Its legal,
commercial, ownership or organizational status,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 341;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo46; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">The
organization, top management, and key personnel,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 342;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo46; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Main
policies,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 343;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo46; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Resources
and premises,<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 344;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo46; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Scope of
accreditation, and<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 345;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" valign="top" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l36 level1 lfo46; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Other such
matters that may affect the ability of the CAB to fulfil for accreditation.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 346;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.2<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Obligations
of the Accreditation Body<o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 347;">
<td rowspan="7" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td rowspan="4" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.2.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall make publicly available information about the
current status of the accreditations that it has granted to CABs. This
information shall be updated regularly. The information shall include the
following: <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 348;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l12 level1 lfo43; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Name and
address of each accredited CAB; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 349;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l12 level1 lfo43; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Dates of
granting accreditation and expiry dates, as applicable; <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 350;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l12 level1 lfo43; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Scopes of
accreditation condensed and/or in full. If only scopes are provided,
information shall be given on how to obtain full scopes.<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 351;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.2.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall provide the CAB with information about suitable ways
to obtain traceability of measurement results in relation to the scope for
which accreditation is provided. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 352;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.2.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall, where applicable, provide information about
international arrangements in which it is involved. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 353;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.2.4<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall give due notice of any changes to its requirements
for accreditation. It shall take account of views expressed by interested
parties before deciding on the precise form and effective date of the
changes. Following a decision on, and publication of, the changed
requirements, it shall verify that each accredited body carries out any
necessary adjustments. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 354;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.3<o:p></o:p></span></span></p>
</td>
<td colspan="2" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 415.95pt;" width="555">
<p class="MsoNoSpacing"><b><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Reference
to Accreditation and Use of Symbols <o:p></o:p></span></span></b></p>
</td>
</tr>
<tr style="mso-yfti-irow: 355;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.3.1<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">An
accreditation body, as proprietor of the accreditation symbol that is
intended for use by its accredited CABs, shall have a policy governing its
protection and use. The accreditation symbol shall have, or be accompanied
with, a clear indication as to which activity (as indicated in Clause 1) the
accreditation is related. An accredited CAB is allowed to use this symbol on
its reports or certificates issued within the scope of its accreditation. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 356;">
<td rowspan="7" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td rowspan="7" style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p align="center" class="MsoNoSpacing" style="text-align: center;"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.3.2<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall take effective measures to ensure that the
accredited CAB<o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 357;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo44; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">a.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Fully
conforms with the requirements of the accreditation body for claiming
accreditation status, when making reference to its accreditation in
communication media such as the internet, documents, brochures, or
advertising, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 358;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo44; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">b.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Only uses
the accreditation symbols for premises of the CAB that are specifically
included in the accreditation, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 359;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo44; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">c.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Does not
make any statement regarding its accreditation that the accreditation body
may consider misleading or unauthorized. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 360;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo44; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">d.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Takes due
care that no report or certificate nor any part thereof is used in a
misleading manner, <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 361;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo44; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">e.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Upon
suspension or withdrawal of its accreditation (however determined),
discontinues its use of all advertising matter that contains any reference to
an accredited status, and <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 362;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing" style="margin-left: 18.0pt; mso-list: l22 level1 lfo44; text-indent: -18.0pt;"><!--[if !supportLists]--><span style="color: #01ffff;"><span style="font-family: "Palatino Linotype",serif; mso-bidi-font-family: "Palatino Linotype"; mso-fareast-font-family: "Palatino Linotype";"><span style="mso-list: Ignore;">f.<span style="font: 7.0pt "Times New Roman";"> </span></span></span><!--[endif]--><span dir="LTR"></span><span style="font-family: "Palatino Linotype",serif;">Does not
allow the fact of its accreditation to be used to imply that a product,
process, system, or person is approved by the accreditation body. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 363;">
<td rowspan="2" style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 34.85pt;" valign="top" width="46">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><o:p><span style="color: #01ffff;"> </span></o:p></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">8.3.3<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">The
accreditation body shall take suitable action to deal with incorrect
references to accreditation status, or misleading use of accreditation
symbols found in advertisements, catalogues, etc. <o:p></o:p></span></span></p>
</td>
</tr>
<tr style="mso-yfti-irow: 364; mso-yfti-lastrow: yes;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 38.7pt;" width="52">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Note<o:p></o:p></span></span></p>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt; width: 377.25pt;" width="503">
<p class="MsoNoSpacing"><span style="font-family: "Palatino Linotype",serif;"><span style="color: #01ffff;">Suitable
actions include request for corrective action, withdrawal, publication of the
transgression and, if necessary, other legal action. <o:p></o:p></span></span></p>
</td>
</tr>
</tbody></table></div>MT Noteshttp://www.blogger.com/profile/17425388568109564486noreply@blogger.com0