May 10, 2006
ADMINISTATIVE ORDER
No. 2006 – 0024
I.
RATIONALE
/ BACKGROUND
In
order to secure public health and safety, Presidential Decree 856 also known as
Sanitation Code of the Philippines mandates the Department of Health to
accredit laboratories performing examination of drinking water in accordance
with the National Drinking Water Standards. In 1979, Administrative Order No.
31 was issued containing the Requirements of the Accreditation of Water
Analysis Laboratories implemented by the Bureau of Research and Laboratories of
the Department of Health.
The
enactment of Executive Order No. 102 series 1999, which re–directs the
functions and operations of the Department of Health, transferred the
regulatory functions of the Bureau of Research and Laboratories to the Bureau
of Health Facilities and Services. The other technical functions of the Bureau
of Research and Laboratories were distributed among the designated National
Reference Laboratories by virtue of Department Order No. 393–E series 2000.
The
safety and potability of drinking water is a public health concern, which can
be safeguarded by accurate and reliable results generated by testing facilities
complying with quality standards stated in the Philippine National Standards
for Drinking Water.
Recognizing
the need to maintain and safe guard water quality, Republic Act 9275 known as
the Philippine Clean Water Act of 2004 was enacted and the Department of Health
was tasked to be responsible for the promulgation, revision and enforcement of
drinking water standards. It is for this purpose that the Bureau of Health Facilities
and Services in coordination with the National Reference Laboratory for
Environmental and Occupational Health, Toxicology and Micronutrient Assay, as
stipulated in their mandates, are tasked to evaluate and monitor the quality of
services rendered by these water testing laboratories nationwide through the
implementation of these rules and regulations in accordance with existing
policies and scientifically accepted practices.
II.
OBJECTIVE
To
protect public health, safety, and welfare by ensuring the accuracy, precision
and reliability of results generated by drinking water testing laboratories
through formulation and enforcement of revised standard for accreditation.
III.
SCOPE AND
COVERAGE
These
rules and regulations shall apply to all Department of Health offices,
including its attached agencies involved in the enforcement of drinking water
standards to all testing laboratories nationwide. It also covers the operation
of government agencies under the various government national agencies and
departments as well as those under the local government at province, city and
municipal levels in so far as the policies and programs affect public health
and those governed by technical guidelines and standards mandated by the DOH.
It further covers private entities (persons and enterprises) engaged in the
provision of health goods and services in so far as the operations are
similarly governed by technical guidelines and standards mandated by the DOH.
Laboratories
for purely academic training and/or research and other laboratories performing
in–house monitoring shall be governed by these rules and regulations.
IV.
DEFINITION
OF TERMS
A.
Accreditation – a formal authorization issued by the DOH to an
individual, partnership, corporation or association seeking to perform drinking
water analysis in compliance with the requirements as prescribed in this Order.
B.
Applicant – an individual, partnership, corporation or
association seeing and accreditation to operate and maintain a drinking water
testing facility.
C.
BHFS – acronym for the Bureau of Health Facilities and
Services of the DOH. It shall exercise the regulatory function provided in this
Order.
D.
CHD – acronym for the Centers for Health Development, the
regional offices of the DOH
E.
DOH – acronym for the Department of Health
F.
Laboratory
– refers to the Drinking Water
Analysis Laboratory. It is a facility that performs either bacteriological,
biological, physical, chemical and radiological analysis, or a combination of
any of these methods, to determine the potability and safety of water.
G.
NRL – refers to the designated National Reference
Laboratory for Environmental and Occupational Health, Toxicology and
Micronutrient Assay.
H.
PNSDW – acronym for the Philippine National Standard for
Drinking Water.
I.
Quality
Manual – documents stating the
quality policy and describing the quality system and quality procedures
intended for the overall planning and administration of activities, which affect
the quality of laboratory services.
J.
Quality
Policy – statements of intentions or
desires of the organization with respect to management of their quality system.
K.
Specimen – collected drinking water sample submitted for
analysis to determine its potability and safety.
L.
Standard
Method – methods of analysis as
prescribed in the PNSDW and/or the Standard Method for the Examination of Water
and Waste Water [joint action of the American Public Health Association (APHA)
, American Waterworks Association (AWWA), and Water Pollution Control
Federation (WPCF)]
M.
Water
Analysis – testing procedures such as
bacteriologic, biologic, physical, chemical, radiological, performed on a water
sample.
V.
POLICIES
AND GUIDELINES
A.
General
Policies
1. The BHFS shall exercise its regulatory function for
the initial issuance of the Certificate of Accreditation and the CHD shall be
responsible for the renewal of accreditation provided that appropriate training
has been given.
2. The NRL shall conduct proficiency testing, confirmatory
testing and personnel training relative the accreditation of the laboratories.
3. Laboratories shall not operate without a valid
Certificate of Accreditation.
4. An accreditation shall be granted in accordance with
prescribed accreditation standards and technical requirements and on the basis
of specific conditions and limitations established during the survey.
5. All accredited laboratories shall be given one (1)
year from approval and publication of these rules and regulations to meet the
new accreditation requirements.
6. The BHFS/CHD on its own based on complaint or charges
duly sworn to by any person, interested party or corporation, against a
laboratory or its personnel to the effect that an accredited laboratory have
violated or are violating the provisions, shall investigate and after due
hearing may modify, suspend or revoke the accreditation of a laboratory for
such period and under such terms may be necessary to ensure full reliability
and accuracy of water analysis and its results.
7. The accreditation of laboratories may be suspended or
revoked by the BHFS/CHD director upon violation of these rules and regulations
or the commission of the following acts by the persons owning or operating the
laboratory and the person under their authority:
a. Issuance of fraudulent water testing results
b. Change in the ownership, location and head of the
laboratory or personnel without informing the BHFS/CHD
c. Refusal to allow survey or monitoring visits of the
laboratory by the person/s authorized by the BHFS/CHD at an appropriate time.
d. Refusal to participate in the proficiency testing
conducted by the NRL.
e. Any material false statement in the application.
8. If upon monitoring visits, the laboratory is found to
be violating these rules and regulations, the BHFS/CHD may immediately
preventively suspend the operation of the said laboratory. Preventive
suspension shall not be more than sixty (60) days.
9. Any laboratory or any of its personnel aggrieved by
the decision of the BHFS/CHD may within fifteen (15) days after receipt of
notice of decision, file a notice of appeal with the Office of the Secretary
and serve a copy of the notice of appeal to the BHFS/CHD. Thereupon, the
BHFS/CHD shall promptly certify and file a copy of the decision including the
transcript of hearings on which the decision is based with the Office of the
Secretary review. The decision of the Office of the Secretary shall be final
and executory.
10. Submitted applications that are not processed within
sixty (60) days shall be granted the Certificate of Accreditation.
11. A laboratory that is a unit/section/division of a
clinical laboratory shall no longer be required to secure a separate
accreditation provided that accreditation standards and technical requirements
to perform examination of drinking water had been met. Hence, the permission to
perform examination of drinking water shall be included in the License to
Operate a clinical laboratory.
12. Laboratories shall be classified according to:
a.
Ownership
(1)
Government – operated and maintained partially or wholly by the
national, provincial, city or municipal government, or other political unit, or
by any department, division, board or agency thereof.
(2)
Private – privately owned, established and operated with
funds through donation, principal, investment or other means, by any
individual, corporation, association or organization.
b.
Institutional
Character
(1)
Institution–based – a laboratory that is located within the premises
and operates as part of an institution.
(2)
Freestanding – a laboratory that is not attached to an institution
and operated independently.
c.
Service
capability
(1)
Bacteriological
analysis – laboratory performs
standard methods to detect and estimate bacterial coliform organisms in the
water sample.
(2)
Biological
analysis – laboratory performs
standard methods to detect and estimate biologic organisms such as planktons in
the water sample.
(3)
Physical
analysis – laboratory performs
standard methods to measure the aesthetic characteristics of the water sample.
(4)
Chemical
analysis – laboratory performs
standard methods to detect and estimate the chemical substances in the water
sample.
(5)
Radiological
analysis – laboratory performs
standard methods to detect and estimate the radioactive contaminants in the
water sample.
B.
Specific
Policies
1.
Technical
Requirements
a.
Physical
Plant
(1)
The laboratory
shall be housed in a permanent building with adequate water and power supply,
drainage and ventilation. It must also be dust– free and must not introduce
contamination.
(2)
The laboratory
workspace shall correlate with the volume and type of analysis to be undertaken
including provisions for periods of peak workload. Freestanding laboratories
shall have at a minimum of twenty (20) square meter workspace requirement.
(3)
The laboratory
workspace shall consist of a sufficient bench top area for sample processing,
storage space for chemicals, glassware and supplies and an adequate area for
cleaning glassware, sterilizing materials and fixed and portable equipment.
(4)
There shall be
separation between neighboring areas where activities therein are not related.
(5)
There shall be
adequate physical provisions for the safety of laboratory personnel.
(6)
The laboratory
shall have provisions for appropriate solid and liquid waste disposal system in
accordance with the current DOH Health Care Waste Management Manual.
b.
Personnel
(1)
The operation of
the laboratory shall be under the direction and supervision of a competent
professional who has management training and at least three (3) years’
experience in the theory and practice of procedures used in water testing. The
head of the laboratory shall have the overall responsibility for the
organizational, professional, educational, administrative and technical
activities of the laboratory.
(2)
The analyst
involved in the performance of laboratory procedures must have the appropriate
baccalaureate degree and at least two (2) years’ experience in water testing
procedures relevant to the service capability of the laboratory.
(3)
The laboratory
aide must have training or at least six (6) months experience on clerical
support and sampling.
c.
Equipment,
Instruments, Reagents and Supplies
(1)
The laboratory
shall have the necessary equipment, reagents and supplies to perform the
testing and analysis and conform with all the requirements of the analytical
methods recommended or approved by the NRL in accordance with the current PNSDW
and the latest locally available Standard Method for the Examination of Water
and Waste Water, AWWA, APHA, WPCF.
(2)
The laboratory
shall maintain records of each item of equipment including maintenance,
calibration and history of damage, malfunction and repair.
d.
Analytical
Methods
(1) The laboratory shall select analytical methods that
are appropriate for the analyte and sample matrix based on the current PNSDW
and the latest locally available Standard Method for the Examination of Water
and Waste Water, AWWA, APHA, WPCF that produce the appropriate quantitative
levels.
(2) Modification of analytical methods is allowed provided
that these are validated and approved by the NRL prior to its use.
(3) Approval of the NRL must be secured by the
laboratories before using other methods of analysis not otherwise specified in
the current PNSDW and the latest locally available Standard Method for the
Examination of Water and Waste Water, AWWA, APHA, WPCF.
e.
Quality
and Technical Manual
(1)
The laboratory
shall develop and maintain a quality manual that is appropriate for the types
of analysis done and the volume of samples tested. The quality manual shall
include systems, and work instructions for document control, sample handling
and acceptance policies, ethics policy statements and management processes and
procedures, and the essential quality control and assurance requirements for
each section of the laboratory.
(2)
All laboratories
shall develop policies and systems for preventive and corrective actions in
cases of unforeseen deviation from standard operating procedures.
(3)
The laboratory
shall develop and maintain a technical manual, which covers the scope of tis
requested accreditation. The technical manual must adequately address method requirements
and reflect the specific laboratory procedures (test principle, interference,
reagent/standard preparation, calibration and quality control procedures, data
evaluation and calculation).
f.
Laboratory
Reports
(1) All laboratory reports must clearly state and reflect
accurate test results, names of the head of the laboratory, analyst and testing
facility.
(2) The head of the laboratory and analyst must affix
their actual signatures to all laboratory reports prior to issuance.
(3) All laboratory reports bearing electronic signatures
of the head of the laboratory and analyst shall be considered valid provided
that the laboratory has procedures in place to guard against improper use of
the electronic signatures and is subject to the provisions and conditions of Republic
Act No. 8972 known as the “Electronic Commerce Act of 2000.”
(4) If opinions and interpretations are included in the
laboratory report, the reference must be stated.
(5) All laboratory reports shall be in the form prescribed
by the DOH.
(6) The results of outsources tests from another
accredited laboratory shall be attached to the original laboratory results.
g.
Laboratory
Records
(1)
The laboratory
shall maintain records in a manner that allows reconstruction of all laboratory
activities, which includes laboratory requests, sampling records, analytical
reports and quality control records.
(2)
The laboratory
shall also maintain personnel records, equipment maintenance, records, computer
programs and electronic data.
(3)
All laboratory
records shall be kept and organized for easy retrieval.
(4)
All laboratory
records shall be retained in the premises for a minimum of five (5) years.
(5)
All laboratory
records shall be disposed after the minimum retention period prescribed by the
NRL.
(6)
All laboratory
records shall be held secure and confidential.
(7)
The laboratory
shall have written plan that specifies how records will be maintained and
transferred in the event that the laboratory transfers ownership or terminate
operations.
h.
Quality
Management
(1) The laboratory shall prepare and adopt a quality
assurance program to establish, maintain and improve the quality of data
generated by the laboratory.
(2) The laboratory shall analyze quality control samples
on each analytical run in order to ensure the proficiency of the analysts and
equipment.
(3) The laboratory shall conduct an internal quality audit
at least every six (6) months.
(4) All quality control charts must be displayed in a
conspicuous place in the laboratory.
(5) All quality control information shall be available in
the laboratory.
i.
Proficiency
Testing
(1) All accredited laboratories must participate in
proficiency testing conducted by the NRL and must achieve satisfactory results
for continued accreditation.
2.
Certificate
of Accreditation
a.
The Certificate
of Accreditation shall reflect the parameters applied for in each service area.
b.
The certificate
of Accreditation is valid for two (2) years and expires on the last day of
December stated therein. Failure to submit an application for renewal of
accreditation within sixty (60) days of the expiration date of the current
Certificate of Accreditation will result in lapse of accreditation and
cancellation of registration. A new application for the issuance of
accreditation shall be required before a laboratory can be allowed to operate.
c.
The accreditation
granted as well as any right under the accreditation shall not be assigned
directly or indirectly to any party.
d.
The BHFS shall be
notified of any change in management name or ownership. In cases of transfer of
location, a new application for accreditation shall be required.
e.
Failure to report
in writing within fifteen (15) days of any substantial change in the condition
of the laboratory (e.g. changes in the physical plant, equipment, or personnel)
may be a basis for the suspension or revocation of the accreditation.
f.
A separate
accreditation shall be required for all laboratories or branches maintained in
separate premises but operated under the same management.
g.
The accreditation
shall be placed in an area readily seen by the public. A copy of the rules and
regulations shall be readily available for guidance of all personnel of the
laboratory.
VI.
PROCEDURAL
GUIDELINES
1.
Any person, firms
or corporation desiring to establish, operate and maintain a laboratory shall
submit to the BHFS/CHD an accomplished application on the prescribed form and
current proficiency test result (if applying for renewal).
2.
The applicant must
pay a non–refundable accreditation fee that is charged for every application
(initial and renewal) according to the DOH prescribed schedule of fees.
3.
Upon receipt of
the application and after payment of the accreditation fee, the BHFS/CHD
representative reviews the application and conducts an on–site survey of the
laboratory to determine compliance with the standards and technical
requirements.
4.
Initial or
renewal of the Certificate of Accreditation is granted only after the BHFS/CHD
has determined by survey that the laboratory has complied with the
accreditation requirements. If the laboratory was not able to comply with the
accreditation requirements, the BHFS/CHD would provide a written report
outlining the laboratory’s deficiencies. The laboratory must respond to the
deficiency report within thirty (30) days and correct all deviations within
sixty (60) days of receipt of onsite report.
VII.
MONITORING
Authorized
representatives from the BHFS/CHD may conduct unannounced, on site visits of
accredited laboratories to monitor and document the continuing compliance to
set standards.
VIII.
SEPARABILITY/REPEALING
CLAUSE
In
the event that 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.
These
rules and regulations shall repeal and supersede all administrative orders and
previous issuances inconsistent thereof.
IX.
EFFECTIVITY
These
rules and regulations shall take effect fifteen (15) days after publication in
a newspaper of general circulation
FRANCISCO T. DUQUE III,
MD, MSc
Secretary of Health
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