Revised Rules and Regulations Governing the Accreditation of Laboratories for Drinking Water Analysis

July 17, 2020

DOH ADMINISTRATIVE ORDER NO. 2020-0031

 

I. RATIONALE/BACKGROUND

Chapter II (Water Supply) of Presidential Decree No. 856 or Code on Sanitation of the Philippines requires the initial and periodic examination of drinking water to be done by a DOH-Accredited water testing laboratory. Further, Republic Act No. 9275 or the Philippine Clean Water Act of 2004 and Administrative Order No. 2006-0024 known as the "Rules and Regulations Governing the Accreditation of Laboratories for Drinking Water Analysis," reiterated the importance to safeguard the safety and potability of drinking water in the country, through the regulation of Laboratories for Drinking Water Analysis (LDWA).

The Department of Health (DOH) through the Health Facilities and Services Regulatory Bureau (HFSRB) and the Regulation Licensing Enforcement Division of Center for Health Development (CHD-RLED), in coordination with the National Reference Laboratory for Environmental and Occupational Health, Toxicology and Micronutrient Assay (NRL-EOHTM), are the agencies tasked to regulate LDWA.

A vital component on the regulation of LDWA is the precision and reliability of the results released by testing facilities, that results should be in accordance with the Philippine National Standards for Drinking Water (PNSDW), which was updated through Administrative Order No. 2017-0010 known as the "Philippine National Standards for Drinking Water of 2017." A review of the current accreditation standards was undertaken by HFSRB. Another development is the enactment of RA 10657 or the Chemistry Profession Act. It was deemed that a revision be done to synchronize with the latest PNSDW, to resolve compliance issues of the LDWA, and to align with other relevant laws.

Revision of Administrative Order No. 2006-0024 was carried out to harmonize with existing guidelines and established technical procedures. Likewise, this will ensure one of the main goals of the Universal Health Care Act which is to have a healthy living condition for all Filipinos. Moreover, this will guarantee access to quality and affordable health products, devices, facilities and services.

II. OBJECTIVE

This policy seeks to provide updated guidelines on the accreditation of laboratories for drinking water analysis to be able to generate accurate and reliable results.

III. SCOPE AND COVERAGE

This Order shall apply to all DOH offices, including its attached agencies, involved in the enforcement of drinking water quality standards and to all accredited LDWA nationwide. It shall cover various government, national and local agencies, private entities, persons and enterprises engaged in testing drinking water.

Drinking water laboratories for purely academic training and/or research and other laboratories performing solely for internal or in-house monitoring shall not be covered by this Order.

IV. DEFINITION OF TERMS

A. Applicant — refers to an individual, partnership, corporation or association seeking a certificate of accreditation to maintain a laboratory for drinking water analysis.

B. Certificate of Accreditation (DOH-COA) — refers to 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 prescribed in this Order. In this Order, accreditation shall mean licensing.

C. Laboratory for Drinking Water Analysis (LDWA) — refers to a facility that performs any or combination of these analyses: microbiological, physical, and chemical analysis, to determine the potability and safety of drinking water.

D. Maximum Allowable Level (MAL) — refers to the highest level of a contaminant that is allowed in drinking-water.

E. Mandatory Parameters — refers to a list of minimum legally enforceable core parameters offered by a laboratory for drinking water analysis which are as follows: Lead, Nitrate, Arsenic, Cadmium, color, turbidity, thermotolerant coliform (E. coli), disinfectant residual, pH, Total Dissolved Solids (TDS).

F. Philippine National Standards for Drinking Water (PNSDW) — refers to the bases for the standards for drinking-water quality, water sampling, and examination and evaluation of results.

G. Quality Manual — refers to documents that state the quality policy, describe the quality system and quality procedures intended for the overall planning and administration of activities, which affect the quality of laboratory services.

H. Quality Policy — refers to statements of intentions or desires of the organization with respect to management of their quality system.

I. Water Sample — refers to the collected drinking water sample submitted for analysis.

J. Water Analysis — refers to a testing procedure/s performed for the determination of microbiological, physical, and chemical qualities of drinking water.

V. GENERAL GUIDELINES

1. All LDWA shall secure a DOH-COA and must comply at all times with the set regulatory standards.

2. The HFSRB and CHD-RLED shall exercise its regulatory function for the initial and renewal issuance of the DOH-COA, respectively.

3. The testing for radiologic or radioactive contaminants in water shall be regulated by the Department of Science and Technology-Philippine Nuclear Research Institute (DOST-PNRI) in accord to its standard protocols.

4. The LDWA shall not perform any examinations or testing beyond the accredited category.

5. The LDWA shall comply with the prescribed standards and requirements listed in the assessment tool. (see Annex A)

6. At the DOH-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-COA of the LDWA.

7. At the Center for Health Development, the Director IV, or in his/her absence or unavailability or when delegated, the Assistant Regional Director (ARD), shall approve the issuance of the DOH-COA of the LDWA.

VI. SPECIFIC GUIDELINES

A. Classification of LDWA

1. Classification by Ownership:

a. 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.

b. Private — privately owned, established and operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization.

2. Classification by Institutional Character:

a. Institution based — a laboratory that is located within the premises and operates as part of a DOH licensed health facility.

b. Non-institution based — a laboratory that operates independently and is not attached to any DOH licensed health facility.

3. Classification by Service Capability:

 

Classification	Service Capability	Minimum Parameters Tested
A	Microbiological	Detects and enumerate coliform organisms (Total coliform, thermotolerant coliforms/E. coli, and HPC) in the water samples.
B	Physico-Chemical	Detects and quantify physical and chemical characteristics of at least the nine (9) mandatory parameters as stated in the 2017 PNSDW namely: Lead, Nitrate, Arsenic, Cadmium, color, turbidity, disinfectant residual, pH, Total Dissolved Solids (TDS).
C	Microbiological-Physico-Chemical	Offers services both Category A and B

 

B. Technical Requirements

1. Physical Plant

a. The laboratory shall be located in a permanent building with adequate water and power supply, proper drainage and adequate ventilation. It must be dust-free and must not introduce contamination.

b. Space requirements shall be based on the activities done within the laboratory. Personnel, fixtures, equipment, sink, etc., shall be considered. Minimum area requirements for each are listed in ANNEX B (Planning and Design Guidelines for Hospital and Other Health Facilities) of A.O. No. 2016-0042 dated December 12, 2016, titled "Guidelines in the Application of Department of Health Permit to Construct." (downloadable from [email protected])

c. The laboratory workspace shall correlate with the volume and type of analysis to be undertaken including provisions for periods of peak workload. A non-institution based LDWA shall have the following MINIMUM WORK SPACE requirement per service capability, excluding support areas such as administrative office, storage area, records room, etc.:

c.1 Classification A — 20 sqm. for sterile room and media preparation area

c.2 Classification B — 50 sqm. for wet chemistry area, ICP/AAS room, Spectrophotometer room, and chemical storage room

c.3 Classification C — 70 sqm. for sterile room and media preparation area, wet chemistry area, ICP/AAS room, Spectrophotometer room, and chemical storage room

d. The laboratory workspace shall have an adequate bench top area for sample processing; storage area for chemicals, glassware and supplies; an area for cleaning of glassware; an area for sterilizing of materials and fixed and portable equipment, and must be well lit.

e. There shall be separation between adjacent areas with unrelated activities.

f. The laboratory shall have an appropriate waste disposal system for solid, liquid, infectious, wastes, which is in accordance with the current DOH Health Care Waste Management Manual, and Department of Environment and Natural Resources-Environmental Management Bureau (DENR-EMB).

g. There shall be adequate physical provisions for effective safety procedures, both for personnel and the public.

2. Personnel

LDWA shall be composed of the following personnel with their corresponding qualifications and functions:

a. Headship

The head of the laboratory shall be a competent and experienced professional, with a specialized skill set related to and proportionate to the laboratory category. The laboratory head is essentially responsible for the operation of entire laboratory, its personnel, functions, and data, all of which shall meet the quality assurance criteria and regulatory requirements.

b. Analysts

The NRL-EOHTM trained analyst involved in the performance of laboratory procedures must have the appropriate degree and at least two (2) years experience in water testing procedures relevant to the service capability of the laboratory.

The following professionals shall be allowed to be an Analyst:

 

Microbiology	Physico-Chemical
Registered Medical Technologist Certified Microbiologist Registered Food Technologist	Registered Chemist Registered Chemical Technician under the supervision of a Registered Chemist

 

For microbiology, professionals contracted practice as analysts prior to the issuance of this Order shall still be allowed.

For water chemical analysis, only a Registered Chemist shall certify the result.

c. The laboratory aide must have at least 8 hours (1 day) appropriate training (may be in-house) in relevant laboratory procedures.

d. The Water Sampler, person who collects water sample, must be certified by the DOH.

3. Equipment, Instruments, Reagents and Supplies

a. The LDWA shall have all the necessary equipment, reagents and supplies to perform the standard method of analysis based on the PNSDW of 2017.

b. The LDWA shall maintain a detailed record of each equipment/instruments such as but not limited to preventive and corrective maintenance, calibration, history of damage, malfunction and repair.

c. The LDWA shall maintain an inventory of reagents and supplies. Detailed description of the reagents, such as but not limited to lot number, manufacturing date, and expiration date, shall also be recorded.

4. Analytical Methods

a. The LDWA shall select appropriate analytical methods for the analyte and sample matrix based on the current PNSDW.

b. Modification of PNSDW analytical methods shall be allowed provided that these are validated and approved by the NRL-EOHTM prior to its use.

c. MAL for each parameter/analyte set forth by the PNSDW shall be strictly followed. Please refer to Annex A of PNSDW 2017 (A.O. No. 2017-0010).

5. Quality and Technical Manual

a. The LDWA 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 (a) systems and work instructions for document control; (b) sample handling and acceptance policies; (c) ethics policy statements, management processes and procedures; (d) essential quality control and assurance requirements for each section of the laboratory; and systems for preventive and corrective actions in cases of unforeseen events and/or deviation from standard operating procedures.

b. The LDWA shall have written administrative policies and procedures for the maintenance of its operation.

c. The LDWA shall develop and maintain a technical manual, which covers the scope of accreditation. Specific laboratory procedures, such as but not limited to test principle, interference, reagent/standard, preparation, calibration and quality control procedures, data evaluation and calculation, shall be reflected on the technical manual.

6. Laboratory Report

a. All laboratory reports must have accurate test results and shall bear the names of the head of the laboratory, analyst and testing facility.

b. The head of the laboratory and analyst must affix their signatures in all laboratory reports prior to issuance.

c. Laboratory reports for chemical analysis shall be certified by the registered chemist and shall bear the registered chemist's seal or the seal of the registered chemist.

d. All laboratory reports bearing electronic signatures of the head of the laboratory shall be considered valid, provided that the laboratory has procedures in place to guard against improper use of the electronic signature and is subject to the provisions and conditions of the "Electronic Commerce Act of 2000" (Republic Act No. 8792). n

e. For outsourced tests, the issued results shall be that of the referral LDWA.

f. All LDWA reports shall include all the information prescribed by the DOH

7. Laboratory Records

a. The LDWA shall maintain complete records of all laboratory activities done from laboratory requests, sampling records, analytical reports, to quality control records.

b. The LDWA shall also maintain personnel records, equipment maintenance records, computer programs and electronic data.

c. All LDWA records shall be kept and organized for easy retrieval.

d. All LDWA records shall be retained and disposed based on the policy of the National Archive of the Philippines.

e. All LDWA records are confidential in accordance with the "Data Privacy Law" (Republic Act No. 10173), and shall be kept in a secure area, protected from theft, tampering, and damaging.

f. The LDWA shall have a written plan on the maintenance and transfer of records in the event of change in ownership or termination of operation.

8. Quality Management

a. The LDWA shall prepare and adopt a quality assurance program to establish, maintain and improve the quality of data generated by the laboratory.

b. The LDWA shall analyze quality control samples for each batch of analysis run in order to ensure the proficiency of the analyst/s and equipment.

c. The LDWA shall conduct an internal quality audit at least once a year.

d. All quality control records and information shall be available in the LDWA at all times.

9. Proficiency Testing

a. All accredited LDWA must participate in annual proficiency testing for microbiological analysis and every three (3) years for chemical analysis conducted by the NRL-EOHTM.

10. Outsourcing

a. The referral laboratory shall be DOH-accredited LDWA with at least the same service capability as the referring laboratory. There shall be a Memorandum of Agreement (MOA) between two contracting parties.

b. Referral or outsourcing of examinations shall only be allowed in cases of machine breakdown, for a certain limited period of time only, which shall not last for more than 3 months. The laboratory test/s or analyte/s to be sent out shall be part of the service capability expected for the particular category of the referring laboratory.

c. For outsourced microbiological tests, the specimen collection site shall be located within a maximum of (100) kilometre radius from the address of the DOH accredited LDWA.

d. Equipment breakdown for one (1) year shall be a basis for suspension of DOH-COA.

C. Certificate of Accreditation

1. The DOH-COA shall reflect all the allowable parameters for each classification.

2. The DOH-COA is valid for three (3) years, effective from January 1 of the first year and shall expire on the last day of December on the third year.

3. The DOH-COA is non-transferrable.

4. The HFSRB shall be notified in writing of any change in management name, ownership, or headship or laboratory personnel. Failure to notify in writing within fifteen (15) days of any substantial change in the condition of the laboratory, i.e., changes in the physical plant, equipment, or personnel, may be a basis for the suspension or revocation of the accreditation.

5. In cases of transfer of location, new application for accreditation shall be required.

6. A separate accreditation shall be required for all LDWA or branches maintained in separate location but operated under the same management.

7. Under the One-Stop Shop Online Licensing System (OSSOLS), a laboratory that is a unit/section/division of a institution-based clinical laboratory shall no longer be required to secure a separate DOH-COA 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 LTO of the clinical laboratory and shall be renewed annually.

8. The DOH-COA shall be placed in a conspicuous area which can be readily seen by the public.

9. A copy of the rules and regulations shall be made available at all times for guidance of all personnel of the LDWA.

D. Application Procedures

1. Any person, firm or corporation desiring to establish, operate and maintain LDWA shall submit an accomplished application form to HFSRB for initial or to CHD-RLED for renewal.

2. A complete application for DOH-COA of an LDWA shall consists of the following:

a. Completely filled out application form;

b. DTI or SEC Registration; and

c. For renewal of DOH-COA for classifications B and C, a Certificate of Authority to Operate from Professional Regulatory Commission-Board of Chemistry in pursuant to the "Chemistry Profession Act" (R.A. No. 10657).

d. Copy of OR payment.

For institution based LDWA under the One-Stop Shop licensing system, 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.

3. All applications, whether initial or renewal, for DOH-COA shall only be granted after the HFSRB/CHD-RLED has determined, by assessment that the laboratory has complied with the accreditation requirements. If, upon assessment, the laboratory was not able to comply with the accreditation requirements, the HFSRB/CHD-RLED shall provide a written report outlining the laboratory's deficiencies. The laboratory must comply with the deficiencies within thirty (30) days. Otherwise, the application shall automatically be denied.

4. The application fee is non-refundable and according to the DOH prescribed application.

5. Upon receipt of the complete application forms, the HFSRB/CHD-RLED representative reviews the application and conducts an on-site assessment of the laboratory to determine full compliance with the standards and technical requirements.

6. Renewal application for DOH-COA shall be submitted to HFSRB/CHD-RLED from October 1 to December 15 only, which is in accordance with 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."

7. Failure to submit an application for DOH-COA within the prescribed period shall be given sanctions under A.O. No. 2019-0004.

8. Submitted complete applications that are not processed within twenty (20) days shall automatically be granted the Certificate of Accreditation.

E. Monitoring

1. Authorized representatives from the HFSRB/CHD-RLED shall conduct unannounced on site visits of accredited LDWA to monitor and document the continuous compliance of the LDWA to the set standards.

2. If upon monitoring visit, the LDWA is found to be violating any of the rules and regulations stated herein relative to its operation, the HFSRB/CHD-RLED may immediately impose preventive suspension, which shall not be more than sixty (60) days, to the said LDWA.

3. Findings during monitoring visits by the PRC Board of Chemist shall be reported to DOH-HFSRB for appropriate action.

F. Violations and Sanctions

1. The accreditation of LDWA may be suspended or revoked by the HFSRB/CHD-RLED Director upon violation of any of these rules and regulations, or upon committal of any of the following acts by the persons owning or operating the LDWA, and/or the persons under their authority:

a. Issuance of fraudulent water testing results;

b. Transferring of laboratory results done by another laboratory to the result form of the referring laboratory;

c. Reporting of test results which are not actually done;

d. Performing laboratory procedures beyond their authorized service capability;

e. Unauthorized use of the name and signature of the head of the laboratory and/or the analysts;

f. Permitting unauthorized or unregistered persons to perform technical procedures;

g. Change in the ownership, location, and head of the laboratory or laboratory personnel without informing the HFSRB/CHD-RLED;

h. Refusal to allow monitoring visits of the LDWA by HFSRB/CHD-RLED authorized personnel at any appropriate time;

i. Any material false statement in the application; and

j. Other violations similar or analogous to the above.

2. Sanctions shall be imposed for the following violations:

 

Violation	Sanction
a. Non-participation to External Quality Assessment Program	1st offense: Stern warning 2nd offense: Php30,000.00 3rd offense: Php50,000.00 4th offense: Revocation
b. Unsatisfactory rating to External Quality Assessment Program	1st offense: Stern warning provided there is a record of corrective action taken. Otherwise, DOH-COA shall be immediately revoked. 2nd offense: Revocation of DOH-COA

 

3. In case of complaints, the LDWA, upon receipt of such by HFSRB, shall be given due process wherein an investigation shall be conducted and the appropriate sanctions for violation meted out. Sanctions may either be suspension or revocation of the COA.

Any LDWA 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 Regulations 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.

VII. ROLES AND RESPONSIBILITIES

1. Health Facilities and Services and Regulatory Bureau (as per A.O. No. 2014-0036)

a. Strictly enforce provisions of this order.

b. To set standards for the regulation of health facilities including LDWA.

c. To create/modify inspection and monitoring tools from time to time.

d. To disseminate regulatory policies, standards and forms for information and guidelines of the Regional Offices.

e. To provide consultation and technical assistance to stakeholder, including regulatory officers from the DOH-CHDs in regulation of LDWA.

f. To inspect and issue DOH-COA for initial application.

g. To conduct unannounced monitoring visits to check for continuous compliance of LDWA.

h. To promptly respond to complaints relative to the operation of LDWA.

2. Center for Health Development-Regulatory, Licensing, and Enforcement Division

a. Strictly enforce the provisions of this Order.

b. To inspect and issue DOH-COA for renewal application.

c. To conduct unannounced monitoring visits to check for continuous compliance of LDWA.

d. To submit quarterly report on Suspicion/Revocation/Cease and Desist Order issued on LDWA not later than the 15th day of the following month.

e. To promptly respond to complaints relative to the operation of LDWA.

3. National Reference Laboratory for Environmental, Occupational Health, Toxicology and Micronutrient Assay (NRL-EOHTM) — a government agency attached to East Avenue Medical Center.

a. Provide laboratory reference/referral services for confirmatory testing.

b. Train laboratory personnel, analysts and the drinking water sampler.

c. Maintain quality assurance program for laboratory tests through proficiency testing.

d. Perform technical evaluation of reagents and diagnostic kits.

VIII. TRANSITORY PROVISIONS

All existing accredited laboratories shall be given two (2) years to fully comply with the new requirements including physical structures from the date of effectivity of this A.O.

For new laboratories, this A.O. shall be strictly followed.

IX. 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 rescind Administrative Order No. 2006-0024, all administrative orders and previous issuances inconsistent thereof.

X. EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication in a newspaper of general circulation and upon filing with the University of the Philippines Law Center of three (3) copies of this Order.

(SGD.) FRANCISCO T. DUQUE III, MD, MScSecretary of Health

ANNEX A

Assessment Tool for Accreditation of Laboratory for Drinking Water Analysis

Part I — Services

Part II — Personnel

Part III — Physical Plant

Part IV — Equipment/Instrument

Assessment Tool for Accreditation of Laboratory for Drinking Water Analysis

Published in the Manila Bulletin on July 29, 2020.

 

n Note from the Publisher: Written as "Republic Act No. 8972" in the original document.