05 August 2017

Administrative Order No. 2006-0024




May 10, 2006

ADMINISTATIVE ORDER
No. 2006 – 0024

RULES AND REGULATIONS GOVERNING THE ACCREDITATION OF LABORATORIES FOR DRINKING WATER ANALYSIS

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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