10 - AO NO 2006-0024: ACCREDITATION OF LABORATORIES FOR DRINKING WATER ANALYSIS

PD 856: Code of Sanitation of the Philippines

Provides that the examination of drinking water should be performed only in water testing laboratories duly accredited by the DOH

AO No 2006-0024

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

Water Station

provides water to the community

Water Laboratory

tests the water if they are safe enough for human consumption

Water

A commodity that one cannot live without

Safe and potable

Water in the communities should be:

Potable Water

It guarantees that the water meets certain standards set by regulatory bodies to ensure it's safe for human consumption, including drinking, cooking, and washing food prep surfaces.

Safe Water

It implies the water won't cause harm if used. This could include water that's okay for showering, washing clothes, or watering plants, but may not necessarily be suitable for drinking.

• Also private entities engaged in the provision of health goods and services

• These rules and regulations shall apply to all DOH offices, and attached agencies, as well as those under the local government at the province, city, and municipal levels

• Manila Water

• Maynilad

Major distributors/holders of water, particularly in Metro Manila

laboratory result for bacteriological analysis

Drinking fountains enable consumption for the general public by providing a ? to ensure that the bacteria present in that particular drinking fountain are not harmful

coliform units of bacteria

Manila Bay was closed for swimming in general because of the ? present

• Academic Training Laboratory

• Research Laboratory

• “Performing in House Monitoring”

All laboratories are governed by these rules and regulations except:

Objective

To protect public health, safety, and welfare by ensuring the reliability of results generated by drinking water testing laboratories

microbiology laboratory

Usually, water testing laboratories in the hospital are part of the

food and water microbiology

It can also be a free-standing laboratory that only specializes in testing water, usually tested by ?

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

Applicant

an individual, partnership, corporation or association seeing and accreditation to operate and maintain a drinking water testing facility

Bureau of Health Facilities and Services / Health Facilities and Services Regulatory Bureau

functions in the initial issuance of the Certificate of Accreditation

Center for Health Development

responsible for the renewal of accreditation

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

National Reference Laboratory

conducts proficiency testing, confirmatory testing, and personnel training relative to the accreditation of the laboratories

East Avenue Medical Center

The National Reference Laboratory for water analysis is still the

East Avenue Medical Center

Toxicology, environmental analysis, and water analysis

Philippine National Standard for Drinking Water

PNSDW

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

Quality Policy

statements of intentions or desires of the organization with respect to management of their quality system

Specimen

collected drinking water sample submitted for analysis to determine its potability and safety

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)]

Water Analysis

testing procedures such as bacteriologic, biologic, physical, chemical, radiological, performed on a water sample

1

All accredited laboratories shall be given ? year from the approval of these rules to meet the new accreditation requirements

Modify, suspend, and revoke the accreditation of the laboratory if they have violated these rules and regulations:

• Issuance of fraudulent water testing results

• Change in the ownership, location, and head of the laboratory or personnel w/o informing the BHFS/CHD

• Refusal to allow survey or monitoring visits of the laboratory by the person/s authorized by the BHFS/CHD at an appropriate time

• Refusal to participate in the proficiency testing conducted by the NRL

• Any material false statement in the application

60

Preventive suspension shall not be more than ? days

15

Notice of appeal may be filed in the Office of Secretary ? days after the receipt of the decision

15

After being suspended, you can still file an appeal, but you have to submit it ? days after the receipt of the decision

final and executory

The decision of the Office of the Secretary shall be ?

60

Submitted applications that are processed within ? days shall be granted the Certificate of Accreditation

no longer be (di na required to get a separate license)

• A laboratory that is a unit/section of a clinical laboratory shall (be/no longer be) required to secure a separate accreditation

  • E.g., If your laboratory is part of the microbiology laboratory

• Government

• Private

Classification according to ownership

• Institutional-based

• Free-standing

According to institutional character

• Bacteriologic Analysis Service

• Biological Analysis

• Physical Analysis

• Chemical Analysis

• Radiological Analysis

According to Service Capability

• To test if the water is really mineral or distilled

• To test if the water has radiological components

Purpose of service capability

Bacteriologic Analysis Service

laboratory performs standard methods to detect and estimate bacterial coliform organisms in the water sample

Biological Analysis

laboratory performs standard methods to detect and estimate biologic organisms such as planktons in the water sample

Physical Analysis

laboratory performs standard methods to measure the aesthetic characteristics of the water sample

Chemical Analysis

laboratory performs standard methods to detect and estimate the chemical substances in the water sample

Radiological Analysis

laboratory performs standard methods to detect and estimate the radioactive contaminants in the water sample

• Microbiological (Class A)

• Physico-Chemical (Class B)

• Microbiological-Physico-Chemical (Class C)

According to Service Capability (REVISED)

Microbiological (Class A)

Detects and enumerate coliform organisms (Total coliform, thermotolerant coliforms/E.coli, and HPC) in the water samples

Physico-Chemical (Class B)

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)

Microbiological-Physico-Chemical (Class C)

Offers services both Category A and B

1. Multiple-Tube Fermentation Technique

2. Gram-Stain Technique

3. IMViC Test

4. Standard Plate Count

5. Fecal Coliform Test

6. Test for fecal streptococcal group

Bacteriological Analysis Service (6)

Multiple-Tube Fermentation Technique

gold standard method for testing the bacteriological analysis of water

Multiple-Tube Fermentation Technique

Testing for the presence of bacteria that are coliforms

Lactose Peptone Broth

MTFT medium

Escherichia coli

Lactose fermenters; Part of the normal flora of the digestive tract

Most Probable Number

Reported in MPN

>1.1 MPN/100 mL

Positive

<1.1 MPN/100 mL

Negative

1. Presumptive Stage Test

2. Confirmed Stage Test

3. Completed Test

3 Stage Tests

• Lactose broth/lauryl tryptose broth + water

• Incubate at 35°C for 24 hours

• Positive → gas formation within 48 hours

Presumptive Stage Test

• EMB (Eosin Methylene Blue Agar) / Endo Agar + Inoculum (24 hrs incubation) = color

• Positive → Brown with a greenish metallic sheen colony

Confirmed Stage Test

• Lactose broth fermentation tube + organism incubate at 35°C for 24-48 hours

• Positive → acid and gas formation

Completed Test

IMViC Test

test to determine and differentiate Enterobacteriaceae

Fecal Coliform Test

• Gram-negative

• Coliform: Already in the digestive tract

  • E.g., Enterobacteriaceae

tests for the fecal streptococcal group

Optional tests

Biological Analysis Service

• Quantitative and qualitative examination of phytoplankton samples

  • Zooplankton and bottom fauna examination

    • Source of food for bottom fauna examination

    • Signifies pollution in water if they are found in our samples

  • Not usually performed by medical technologists

• Color

• pH value

• Turbidity

• Lead

• Nitrate

• Disinfectant residuals

Physical and Chemical Analysis Service (Standards; 6)

• Gross Alpha and Gross Beta Radioactivity

• Total Radioactive Strontium in Water

• Total Radium (Precipitation Technique)

• Other radiological tests

Radiologic Analysis Service

• Permanent building w/ adequate water and power supply, drainage, and ventilation

• Dust-free and must not introduce contamination

• 20 sq. m workspace for a free-standing laboratory

• Sufficient bench top for processing, cleaning, and storage

• Adequate physical provision for lab personnel safety

• Appropriate solid and liquid waste disposal system in accordance with DOH Health Care Waste Management Manual

Technical Requirements

20 square meters

Class A

50 sqm

Class B

70 sqm

Class C

• Head

• Analyst

• Laboratory Aide

Personnel

Head

can be a sanitary engineer, chemist, medical technologist, or pharmacist

3

Head must have management training and at least ? years experience in water testing

Analyst

must have a baccalaureate degree and at least 2 years experience in water testing

Laboratory Aide

must have at least 6 months of experience in clerical support and sampling

• RMT

• Certified Microbiologist

• Registered Food Technologist

Personnel for Microbiological

• Registered Chemist

• Registered Chemical Technician

Personnel for Physico-Chemical

• Test results

• Head

• Analyst

• Testing Facility

Laboratory Reports must clearly state accurate ?, name of the ?, ?, and ?

head of the laboratory, analyst

The ? and the ? must affix their actual signatures to all lab reports prior to issuance

electronic signatures

All laboratory reports must bear the ? of the head of the lab and the analyst shall be considered valid

DOH

All laboratory reports shall be in the form prescribed by the

attached to the original laboratory

The results of outsourced tests from another lab shall be ?

Outsourced Tests

These are not done inside the laboratory but are sent to partner laboratories that can perform the particular test

5

Laboratory Records shall be retained for a minimum of ? years

NRL

Laboratory records shall be disposed of after the minimum retention period prescribed by the ?

confidential

Laboratory records shall be held secure and ?

6 months, yearly

Internal quality audit will be conducted at least every ? months (OLD)

(NEW) → ?

Licensed Clinical Pathologist

• Supervises the:

  • Operation if the water analysis lab is attached to a licensed clinical laboratory

• Pharmacist

• Medical Technologist

• Chemist

All laboratory assistants involved in a physical, bacteriological, chemical, biological, and radiological examination of water, should either be a:

Biology Graduate

May undertake biological analysis under the supervision of a registered professional

• 1 registered professional (PMC)

• 1 laboratory assistant

• 1 laboratory aide

Each service must be operated by at least:

30, 5

A bacteriological service with a minimum number of personnel (3) may handle at most ? samples/day and a chemical service of at most ? samples for routine chemistry

2

The certificate of accreditation is valid for ? years (Drinking Water Analysis Laboratory only)

December

The accreditation of a water analysis laboratory shall expire on the last day of ? of the year stated therein, including the authorization given to the head or supervisor of operation

60 days

Failure to submit an application of renewal within ? of the expiration date will result in a lapse of accreditation and cancellation of registration. A new application will be required

management name or ownership in cases of transfer of location

The BHFS shall be notified of any change in ?, and a new application for accreditation shall be required

15 days

Failure to report in writing within ? may be a basis for suspension or revocation