18 November 2005
ADMINISTRATIVE ORDER
No. 2005 – 0032
GUIDELINES ON QUALITY
ASSURANCE PROGRAM (QAP) FOR ALL HIV TESTING LABORATORIES
I. RATIONALE
/ BACKGROUND
HIV/AIDS
is one of the diseases that have to be combated as reflected in the Millennium
Development Goal, proposed issuance attuned to the said international
commitment. This is also being addressed in the Medium Term Development Plan
and the national directions/thrust. To sustain this goal, HIV testing
laboratories have to be standardized to maintain quality results for proper
diagnosis of HIV/AIDS. The STD/AIDS Cooperative Central Laboratories/San Lazaro
Hospital (SACCL) was designed as the National Reference Laboratory (NRL) for
HIV/AIDS, Hepatitis and STIs. Pursuant to the Department Order No. 393–E
series 2000 of the Department of Health, the functions of the NRL–SACCL/SLH
are the following:
· To maintain
Quality Assurance Program (QAP) for laboratory tests – in coordination with the
Bureau of Health Facilities and Services, Department of Health (DOH);
· To provide
laboratory referral services, e.g. for confirmatory testing, surveillance,
research;
· To train
laboratory personnel;
· And to evaluate
the kits and reagents in coordination with the Bureau of Food and Drugs (BFAD)
and the Bureau of Health Devices and Technology (BHDT), DOH.
The
NRL–SACCL/SLH has fully developed their service capabilities including QAP for
HIV, Hepatitis B, Hepatitis C and other Sexually Transmitted Infections. NRL–
SACCL/SLH is responsible for all referrals from private and government
laboratories for confirmatory tests and for resolution of discrepant and
conflicting HIV test results.
The
Quality Assurance Program (QAP) guarantees the accuracy of the final
results reported by a laboratory. It involves proper training of laboratory
personnel in handling specimens, reviewing transcriptional measures, verifying
final results, and using most reliable assays. The External Quality Assessment
Scheme (EQAS) is established to evaluate the effectiveness of the QAP. EQAS is
an external evaluation of a laboratory’s performance using a proficiency
panels. Failure of the HIV testing center to obtain satisfactory rating
indicates deficiencies with the Quality Assurance / Quality Control (QA/QC)
procedures in the laboratory.
All
HIV testing laboratories need to be fully established and monitored through the
QAP to assess and improve the quality of testing and performance of these
laboratories.
II. STATEMENT
OF POLICY
It
is the policy of the DOH to initiate health reforms to ensure quality health services.
NRL–SACCL/SLH is responsible in the establishment of a QAP in support to the Bureau
of Health Facilities and Services (BHFS) requirements in order to upgrade,
assess and monitor the quality of performance of all HIV testing laboratories.
III. SCOPE
Those
guidelines shall apply to all HIV testing laboratories.
IV. OBJECTIVES
1. To establish and promote Quality Assurance Program for
all HIV testing laboratories.
2. To provide training for Medical Technologists
performing HIV testing.
3. To strengthen coordination thru networking among HIV
testing laboratories.
V. DEFINITIONS
OF TERMS
Quality
Assurance – an overall program that
ensures that the final results reported by the laboratory are correct as
accurate as possible
Quality
Assessment – is a means to determine
the quality of results. It is usually an external evaluation of a laboratory’s
performance that relies on incorporating proficiency panels of well–characterized
sera into the testing routine. It
challenges the effectiveness of the quality assurance program.
External
Quality Assessment (EQAs) Panels – a
set of serum samples that is used to validate the performance of laboratories
which are sent in support of the external proficiency program designed to
determine the ability of the laboratories to accurately test samples and report
results.
External
Quality Assessment Scheme (EQAS) – an
external evaluation of a laboratory’s performance using proficiency panels and
assessed by the National Reference Laboratory for HIV/AIDS, Hepatitis and STIs.
Failure of the HIV Testing Center to obtain satisfactory rating indicates
deficiencies with the Quality Assurance/Quality Control (QA/QC) procedures in
the laboratory. Further, failure to participate in authorized EQAs shall be
grounds for suspension, non–renewal or revocation of the HIV accreditation of
the laboratory.
EQAS
Participants – laboratories
participating in the External Quality Assessment Scheme conducted by the NRL–SACCL/SLH
Training
Participants – medical technologists
who are undergoing HIV proficiency training either for initial HIV accreditation
or renewal of HIV proficiency licenses
Proficiency
Certificate – refers to the citation
received by the medical technologists after they have undergone initial and
renewal of HIV proficiency training.
Certificate
of Qualification – refers to the certification
issued after the clinical laboratory has achieved satisfactory results in EQAS.
Certificate
of Participation – refers to the
certification issued after the clinical laboratory has participated in EQAS.
VI. QUALITY
ASSURANCE GUIDELINES
A. REQUIREMENTS
FOR QUALITY RESULTS
1. Recording
(a) Record
Keeping
An
efficient HIV laboratory shall be able to monitor the records of specimens from
the time the samples are received until the time the results are released.
Appropriate logbooks are essential step in recording. It must be kept
confidential and must include the following:
(1) Name and/or specimen identification
(2) Address or source of specimen
(3) The date of sample collection
(4) The name of requesting physician
(5) The specific test required
(6) Adequacy of samples received
(b) Worksheets
This
serves as a work map for each test run. This should be filled up before the
test is performed and must be kept for a permanent record. The results after
each test run should be reflected in the worksheets and should also contain the
following:
(1) Kit lot number
(2) Expiration date
(3) Date of performance
(4) Medical Technologist’s initial
(5) Supervisor’s signature
(c) Daily log
sheets
This
includes the daily records of temperature of water baths, incubators,
refrigerators and freezers or any documents to show that the operating
conditions of this equipment are maintained appropriately.
(d) Reviewing
of transcriptional measures
Transcriptional
or clerical error includes mistakes made during the transfer of information
from the test readout to the worksheet and from the worksheet to the computer
or report form. System must be developed to re–check results in each of these
steps. The following mechanism shall be observed:
(1) Have a second proficient medical technologist read the
results from the instrument/worksheet/computer to another technologist who will
check the final result; and/or
(2) Have a supervisor check all results at the end of the
day, before releasing the results of the laboratory.
2. Testing
(a) Testing
algorithm for HIV testing
All
HIV testing laboratories must establish their own testing algorithm patterned
on the NRL–SACCL/SLH algorithm depending on the service capability they have.
The NRL–SACCL/SLH testing algorithm is indicated in Annex 1 for both screening
and confirmatory tests. This will serve as a guide for the laboratory personnel
in the proper interpretation and management of HIV diagnosis.
(b) Verification
of true positive and true negative
For
samples found to be “reactive” by screening test, an aliquot from the initial
specimen should be re–tested. These specimens can be retested using an assay
based on an alternative principle, or supplemental test.
Samples
are labeled as “reactive” when results show such by screening methods. These
are labeled “positive” only after verifying the result through testing with a
confirmatory assay.
Repeatedly
reactive results by a screening assay supported by a positive confirmatory
assay are sufficient to verify positivity. However, any confirmatory assays
performed shall be validated by the NRL–SACCL/SLH using the same and/or other
confirmatory assays before the final result is released Annex 2. Laboratories
other than NRL can perform confirmatory test only if deputized by the
Philippine National AIDS Council upon recommendation of NRL–SACCL/SLH.
Verification
of negative results is also important in screening blood for transfusion. A
representative sample (10%) of initially nonreactive specimens may be retested
by the National Reference Laboratory – RITM for confirmatory testing of blood donors
and blood units.
(c) Parallel
testing of resubmitted specimen
Parallel
testing should be done on specimen which yielded indeterminate results. The
first specimen must be withheld until the resubmitted specimen is received some
time later, and then, both specimens are retested in parallel during the same
run, observing changes in reactivity. Specimens with indeterminate results
shall be retested and validated by the NRL–SACCL/SLH for verification and
confirmation prior to the release of the final results.
3. Requirements
for Reporting of Results
Handling
of results must be controlled in order to maintain confidentiality and the
rights of the tested individual upheld. Positive HIV test results are reported
to the submitting physician, who in turn will recommend further appropriate
counseling of the tested individual. A policy decision on the handling and reporting
of results must be enforced to Section 43 of the IRR of R.A. 8504.
In
the HIV diagnostic system, causes of incorrect and misleading reports are the
following:
(a) Reporting of reactive screening assay results without
confirmatory testing;
(b) Use of obsolete Western Blot interpretive criteria;
(c) Reporting “HIV ANTIBODY POSITIVE” or the like without
specifying the method(s) used in the assay.
Indeterminate
result shall be reported with care indicating the importance of resubmission of
follow–up specimen to ensure that the clinician understands the significance of
such results. Results should be clearly indicated on the report form and should
provide comments as necessary.
Referral
of reactive samples must indicate the following information to NRL – SACCL/SLH:
(a) Name/Laboratory code of patient
(b) Age/Sex
(c) Date of specimen received
(d) Address
(e) Requesting physician
(f) Screening Assay result (name of kit & lot number
used, COV and patient’s absorbance for EIA)
(g) Remarks and comments
(h) Signature of the proficient medical technologist
(i) Signature of the Pathologist
Reporting
of confirmatory results and/or validation of test results must indicate the
following information:
(a) Name/Laboratory code of patient
(b) Age/Sex
(c) Date of specimen received
(d) Address or source of specimen
(e) Requesting physician
(f) Screening Assay results (name of kit & lot number
used, COV and patient’s absorbance for EIA)
(g) Confirmatory Assay results (name of kit & lot
number used, bands present and/or reactivity of IF results, if any)
(h) Remarks and comments
(i) Signature of the proficient medical technologist
(j) Signature of the Pathologist
4. Storage of
reactive and indeterminate specimen for follow –up testing
Reactive
serum specimen must be stored in –20oC for follow up testing containing
a minimum of 500 ul volume, and placed in a plastic screw capped vial. A log
book containing all the pertinent information should be capable of identifying
stored samples. To preserve the integrity of samples, aliquot into several
vials is recommended. This avoids repeat freezing thawing.
Stored
serum specimen must be labeled properly using water proof fine point marking
pens.
5. Specimen
transport for referral to NRL–SACCL/SLH
Reactive
specimen subject for confirmatory and/or validation of tests results must be
submitted and transported with care. The specimen must be packed with the
following instruction indicated in Annex 3 to ensure the safety of the
personnel handling the specimen during transport. A written communication must
be attached independently outside the package where the serum specimens are
kept. It is appropriate to declare that the samples are potentially infectious
and written clearly in the package. Transport of specimen by air freight should
follow the aircraft’s rules and regulations.
B. Standard
Operating Procedure (SOP)
Standard
Operating Procedures (SOPs) should be adhered to in the laboratory at all
times. It includes the detailed protocols, principles and explanations of all
the procedures performed within the laboratory. The laboratory manager shall
monitor the performance of the proficient medical technologists to ensure that
the SOPs are being followed. Package inserts can be used as a reference but not
as substitute for the SOPs.
C. Monitoring
of Laboratory Personnel
Known
samples (or samples already tested) must be provided by the laboratory manager
to monitor the performance of the proficient medical technologists. These known
samples are resubmitted discreetly along with the routine workload. The
proficient medical technologist should not be aware when these samples are
submitted to prevent preferential treatment.
D. Quality
Control (QC)
1. Internal
Controls
The
internal controls provided inside the test kit shall be used only with the lot
number of the corresponding test kit during the assay. A full set of controls
recommended with the manufacturer’s instructions must be included in every test
run. Validity of test runs must be observed based on the criteria of the test
kit performance. Results of the controls that are out of range invalidate the
entire test and repeat tests. In such instances, repeat test runs are needed.
2. External
Controls
These
should be included on each HIV test run to monitor consistent performance,
lot–to–lot variation between kits and to serve as an indicator of assay
performance on samples that are borderline reactors.
Criteria for external controls:
(a) Strong known
positive and negative samples (pooled from daily samples or from kit controls)
which are properly filtered with 0.8 um filter or inactivated at 56oC
for 30 minutes.
(b) Borderline
reactor (near the cut–off O.D.) which has the ability to determine out of range
samples.
Any
tests that are rejected due to out–of–range control values may likely be
attributed to true systematic error. However, if a dramatic shit is noted in
the external control value when changing lot numbers, the manufacturer should
be notified to resolve the problem. A second external control can be run in
parallel to determine if the change is significant enough to affect both
external controls.
E. Preventive
Maintenance and Calibration
Individualized
maintenance schedules should be set up for each laboratory depending on the
equipment utilized. Preventive maintenance schedules should be included in the
operating instructions of laboratory instruments for use of ELISA readers and
washers. Maintenance and calibration procedures should be done regularly for
optimal performance of equipment. Performance of schedules maintenance
activities should be documented for future reference.
VII. GUIDELINES
ON EXTERNAL QUALITY ASSESSMENT SCHEME (EQAS)
It
is an external evaluation of laboratory performance that relies on
incorporating proficiency panels of well characterized sera into the testing
routine. The NRL– SACCL/SLH shall conduct external quality assessment to all
accredited HIV testing laboratories once a year to determine the quality of
results delivered.
External
quality assurance shall be diligently practiced to be able to meet the need and
expectations of the medical community by producing highly reliable results. The
NRL–SACCL/SLH shall conduct the External Quality Assessment Scheme (EQAS) on
HIV as well as other STIs such as Hepatitis B, Hepatitis C and Syphilis in
support to the National AIDS Prevention and Control Program of the Department
of Health. EQAS Participation of other blood borne Sexually Transmitted
Infections (STIs) shall depend on the service capabilities of a certain HIV
testing laboratory.
A. Participation
to EQAS
1. Requirements
for the participation
a. Duly accomplished
application form to register for participation in EQAS which (a prototype of
the referral forms are posted at the DOH website: www.doh.gov.ph/saccl). Application fee to defray the cost of preparation
and freight of sending unknown samples.
2. Procedure
for the EQAS participation
a. EQAS participants
shall accomplish forms provided by the NRL – SACCL/SLH for the EQAS;
b. Qualified
participants shall receive the EQAS panels after application fee has been paid
directly to San Lazaro Hospital.
c. Participants
shall perform the test in their respective facilities within 7 working days
upon receiving of the panel as part of their daily routine of HIV testing as
well as HBV and HCV. Report forms are provided by the NRL – SACCL/SLH.
d. Submission of
EQAS original result must be done within 30 days.
e. Unknown panels
must be kept in freezer until results of EQAS are released. In cases of
discordant results, the panels will be retested by the participants during the
monitoring process.
f. Summary of EQAS
results on nationwide coverage will be disseminated to all participants after
the analysis of the results.
B. Conditions
of Satisfactory and Unsatisfactory Results
1. Participants
obtaining satisfactory results in all HIV, HBV and HCV testing will be
considered as garnering a passing score of 100% and will receive a Certificate
of Qualification.
2. Participants
obtaining an unsatisfactory result below 100% to HIV panels will be subject for
supervisory visit. Any discordant results obtained on the said panels will be
monitored by repeat testing or will be given another set of panels as the case
maybe.
3. Certificate of
Participation shall be granted to participants obtaining unsatisfactory results
after the supervisory visit. A recommendation to BHFS shall be forwarded to
address the problem for further evaluation and appropriate action.
VIII. TRAINING
All
HIV testing laboratories are dependent on the quality of work generated as part
of the Quality Assurance Program by the proficiency of the medical
technologist. HIV proficiency training of medical technologist shall be
provided by the NRL–SACCL/SLH to maintain the effectiveness of the quality
assurance and for accreditation purposes.
A. Requirements
of initial HIV proficiency training
a. Accomplished application form provided by the NRL–SACCL/SLH
(a prototype of the application forms are posted at the DOH website: www.doh.gov.ph/saccl).
b. Photocopy of PRC ID;
c. Letter of endorsement from the Pathologist or Head of
Agency and certification that he/she is a practicing technologist in laboratory
work;
d. Registration fee to be paid directly to San Lazaro
Hospital to defray the cost of the training materials, reagents and serum panel
preparations.
B. Scope of
the Proficiency training
a. Laboratory safety and precautions and waste management
b. Laboratory screening methods for HIV and HCV antibody,
HBsAg and Syphilis including principles involved, methodology and technical
trouble shooting, QC/QA Program
c. Nature of HIV infection, epidemiology, clinical
manifestation and laboratory diagnosis, social, ethical and legal aspects of
HIV infection
d. Pre–post donations/test counseling
e. HIV accreditation for clinical laboratory
C. HIV
Proficiency Training shall be based in the following:
a. Lectures/discussions
b. Practicum/hands
on
c. Demonstration
d. Discussion of
problem cases
e. Pre and post
written exams, quizzes and practical examinations
D. Duration
of HIV proficiency training
The
training shall be conducted in a maximum of 7 working days
E. Requirements
for renewal of HIV Proficiency Certificate at the NRL–SACCL/SLH
a. Accomplished application form for the renewal of HIV
proficiency certificate provided by the NRL–SACCL/SLH (a prototype of the
application forms are posted at the DOH website: www.doh.gov.ph/saccl) and such must be signed by the Pathologist of the
sending agency;
b. Photocopy or previous HIV proficiency certificate;
c. Quarterly census form for HIV and other blood–borne
infections;
d. Certificate of performance signed by Pathologist or
Chief Medical Technologist;
e. Certificate of training, seminar or convention
(related to HIV and other blood–borne infection);
f. 2 copies of 2x2 colored ID picture with white
background;
g. Renewal fee (depending on the category of the
applicant) to be paid directly at the San Lazaro Hospital.
F. Exemptions
for non–renewal of HIV Proficiency Certificate
Any
three (3) of the following will be qualified for the exemption in the renewal
of HIV proficiency certificate:
a. Those who are
consistently practicing HIV testing serology certified by the current head of
the laboratory;
b. Trainers of HIV
proficiency workshops;
c. Those HIV
proficient medical technologist currently in the service of any NRLs designated
by the DOH
d. HIV proficient
Medical Technologists who have been engaged in research involving HIV,
Hepatitis B & C and Syphilis.
Anybody
who qualifies for exemption are required to submit the minimum requirements as
stated in section E except for the renewal fee.
G. Categories
of Proficient Medical Technologist requiring renewal of certificate:
a. Category I – Medical Technologist performing HIV test with proficiency
certificate acquired after year CY 2001 shall undergo training seminar update
b. Category
II – Medical Technologists performing
HIV test with proficiency certificate acquired before CY 2000 shall undergo
refresher course.
c. Category
III – non–performing HIV proficient
medical technologist and those with expired proficiency certificates shall
undergo initial HIV proficiency training for reinstatement.
H. Issuance
and content of certificate of proficiency and EQAS qualification
a. The initial HIV proficiency
certificate shall state the name of the medical technologist, the name of the
laboratory he/she is currently connected, certificate number and validity
period of the certificate.
b. The certificate
for renewal of HIV proficiency shall state the name of the medical
technologist, name of the laboratories he/she is connected, certificate number
and validity period of the certificate.
c. Issuance of
certificate of qualification signed by the head of the NRL– SACCL/SLH will be
given after the laboratory has complied with the necessary requirements for
EQAS participation stating the name of the participating laboratory,
satisfactory result and validity period.
d. Issuance of the
certificate of participation will be given after the laboratory has complied with
the necessary requirements for EQAS participation after supervisors
visit/monitoring activities stating the name of the participating laboratory.
I. Limitation
and the use of proficiency certificate in handling HIV testing laboratories:
In
order to sustain the quality performance of a proficient medical technologist,
his/her services must be limited into two (2) HIV testing laboratories only.
Any necessary amendments concerning the content of the proficiency certificate
for HIV, Hepatitis and STI shall be reviewed and amended by the NRL–SACCL/SLH.
IX. MONITORING
Monitoring
of EQAS participants shall be conducted to facilities who obtain unsatisfactory
results. Participants will be subjected to strict observation during the
performance of test panels. The spontaneous monitoring shall document the
overall quality performance of the laboratory tests and shall recommend proper
resolution of errors observed during monitoring by the NRL–SACCL/SLH.
X. VALIDITY
1. EQAS certificate
of participation shall be valid only for one (1) year;
2. EQAS certificate
of qualification shall be valid for two (2) years, provided that the
participant obtained two consecutive satisfactory EQAS results;
3. HIV proficiency
certificate shall be valid only for three (3) years.
XI. GROUNDS
FOR NON–ISSUANCE OF CERTIFICATE OF PARTICIPATION
The
following violations shall be grounds for non–issuance of certificate of
participation
1. The use of unregistered/or expired certificate of
product registration for HIV test kits and reagents;
2. Performance of HIV testing without valid proficiency
training certificate;
3. Unauthorized use of proficiency certificate by
non–proficient medical technologist performing the test.
4. Switching of EQAS panels to and from other HIV
facilities;
5. Falsification of documents pertinent to EQAS results.
XII. SEPARABILITY/REPEALING
CLAUSE
In
the event that any section, paragraph, sentence, clause or word of this order
is declared invalid for whatever, any reason, other provisions thereof shall
not be affected thereby.
These
guidelines shall repeal and supersede all administrative orders and previous
issuances inconsistent thereof.
XIII. EFFECTIVITY
These
guidelines shall take effect fifteen (15) days after its publication in a
newspaper of general circulation.
FRANCISCO T. DUQUE III,
MD, MSc.
Secretary of Health 
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