DRUG TESTING IN THE PHILIPPINES

The best practices for drug testing in the Philippines are based on the general
principles that have been established internationally. They are designed to
ensure that the entire drug testing process is conducted to give accurate and
reliable information about client/donor/subject’s drug use.

Background

Republic Act 9165 otherwise known as the “Comprehensive Dangerous Drugs Act
of 2002” mandates the Department of Health to oversee and monitor the
integration, coordination and supervision of all drug rehabilitation, intervention,
after-care and follow-up programs, projects and activities as well as the
establishment, operation, maintenance and management of privately-owned
drug treatment rehabilitation centers and drug testing networks and laboratories
throughout the country, in coordination with DSWD and other agencies. The
responsibility of the DOH, through the Bureau of Health Facilities and Services
(BHFS, formerly the Bureau of Licensing and Regulation), is to license and
accredit drug-testing laboratories (DTL) to assure the quality, competence and
integrity in the conduct of drug testing.

The East Avenue Medical Center is designated as the National Reference

Laboratory (NRL) for Environmental and Occupational Health, Toxicology and
Micronutrient Assay by virtue of Department Order No. 393-E s. 2000. The NRL
in coordination with BHFS shall assure the competence, integrity and stability of
drug testing centers nationwide.

Objectives
1. Standardize the procedure of drug testing services in the Philippines
among all stakeholders
2. Implement quality assurance program in drug testing laboratories
nationwide.

Scope
This covers all accredited government and private drug testing laboratories in the
Philippines.

Functions

The BHFS is mandated to formulate and establish the standards for regulation of
hospitals, clinics and other health facilities and to enforce standards that shall be
the basis of issuance of license/accreditation of a facility. In accordance with this
mandate, BHFS shall be tasked to:
 a) Develop policies and guidelines on establishment, operation and
monitoring of drug testing laboratories.
b) Conduct accreditation of all private and government drug testing
laboratories.
c) Conduct training of DOH regulatory officers.
d) Conduct research and development of drug testing and other related
activities

The NRL for Environmental and Occupational Health, Toxicology and

Micronutrient Assay is mandated with the following functions:
a) Develop comprehensive procedural and scientific standards for all
aspects of drug testing program.
b) Promote quality assurance program in all drug testing laboratories.
c) Assist DOH designated agencies in the conduct of accreditation of
confirmatory laboratories for drug testing and in the evaluation of test
kits and reagents.
d) Resolve conflicting/challenge results among confirmatory laboratories.
e) Train technical staff of drug testing laboratories.
f) Conduct research and development of drug testing and other related
activities.

LABORATORY PERSONNEL

The laboratory must have suitable qualified personnel.

DTL Owner

Head of Laboratory

Technical Personnel Administrative Personnel

Analyst Clerk
Authorized Specimen Collector Secretary
Laboratory Aide

Organizational Chart

Qualifications of Personnel

Head of the Laboratory

1. In a Screening Laboratory must be
 a) a licensed physician certified in Clinical Pathology by the
Philippine Board of Pathology; or
b) a licensed physician trained in laboratory management and
drug testing operation.

2. In a Confirmatory Laboratory must be

a) a licensed physician certified in Clinical Pathology by the
Philippine Board of Pathology with at least two (2) years of
active laboratory experience in analytical toxicology, or
b) a licensed chemist with Master’s degree in Chemistry,
Biochemistry or a branch of chemistry and at least two (2)
years active laboratory experience in analytical chemistry.

NOTE: In cases where a drug-testing laboratory is a division, section or

unit of a Clinical Laboratory, it may be headed either by a licensed
physician, chemist, medical technologist, pharmacist or chemical
engineer.

The Head of the Laboratory must have the following training in:
a) Theory and practice of the drug testing procedures used in the
laboratory;
b) Chain of custody, reporting, and record keeping;
c) Review and interpretation of test results;
d) Quality assurance program; and
e) Dangerous drugs regulations and policies.

The Head of the Laboratory has the following functions and

responsibilities:
1. Administrative
a) Has general and overall supervision of the facility and all
aspects of laboratory work;
b) Has general supervision and conduct of all laboratory personnel;
c) Formulates and implements standard operation manual that
govern the operation of the DTL. This shall be periodically
reviewed and updated;
d) Prepares financial and annual reports of the laboratory;
e) Provides other administrative support services such as
communications, security and maintenance services.

2. Technical
a) Supervises and directs all analytical procedures of the
laboratory;
b) Assures quality of all laboratory test results;
c) Issues, signs out and interprets laboratory results;
 d) Evaluates and recommends reagents, supplies and equipment;
e) Reviews the CCF and reports received from authorized
collector;
f) Interviews the Client/Donor/Subject, if necessary;
g) Reviews pertinent medical records of Client/Donor/Subject, if
necessary;
h) Cancels the results of all specimen which are not collected or
tested not in accordance with the DTL manual;
i) Reviews, rejects, and refers for confirmation and retesting all
specimen and test results that are positive, adulterated,
substituted or invalid;
j) Implements remedial actions necessary to maintain satisfactory
operation and performance in the laboratory;
k) Directs protocol for preventive maintenance of equipment;
l) Provides comprehensive, continuing training and education of
personnel related to conduct of DTL.

Analyst
The personnel must be a registered
1. Chemist
2. Chemical Engineer
3. Medical Technologist
4. Pharmacist

The analyst must have training in the following:

a) Analytical methods and procedures;
b) Maintenance of chain of custody;
c) Reviewing and reporting test results;
d) Proper remedial action in response to problems that may arise;
e) Quality control procedures and practices;
f) Dangerous drugs regulations and policies.

The functions and responsibilities of the analyst are as follows:

a) Verifies the completeness of Custody and Control Form (CCF);
b) Prepares specimen for analysis;
c) Examines, processes and analyzes specimen for drug testing;
d) Interprets, records, releases and signs out laboratory results;
e) Assists in the implementation of quality assurance program;
f) Assists in the evaluation of reagents, supplies and equipment;
g) Refers to the Head of the Laboratory as the need arises.

Authorized Specimen Collector

There shall be a designated authorized personnel within the laboratory to
collect the specimen who must
 1. Be at least a high school graduate
2. Have undergone appropriate training

An Authorized Specimen Collector must have undergone training in:

a) Collection procedure for each type of specimen;
b) Chain of custody and record keeping;
c) Specimen integrity and security; and
d) Dangerous drugs regulations and policies.

Retraining of Authorized Specimen Collector shall be required under the

following conditions:
a) The collection procedure changes significantly (e.g., a new CCF
is used); or
b) The Authorized Specimen Collector made a mistake that caused
a test to be cancelled.

The Authorized Specimen Collector must observe the following to ensure

the security of a specimen at the collection site:
a) Restricts unauthorized personnel to enter the collection site
during collection;
b) Verifies identity of the Client/Donor/Subject;
c) Provides security to specimen supplies, records and documents
at collection site;
d) Informs the Client/Donor/Subject the procedures of specimen
collection;
e) Performs only one specimen collection at a time;
f) Accepts and seals the specimen container in the presence of the
Client/Donor/Subject;
g) Accomplishes CCF.

The following are persons who are not authorized to collect specimen:
a) Employer of the Client/Donor/Subject
b) Investigator at the crime scene
c) Complainant
d) Owner/Administrator of establishment

Other Laboratory Personnel

1. Each personnel must have the educational background appropriate for
the tasks assigned.
2. Each personnel must have appropriate training and preferably with
experience.
 Evaluation and Personnel Development

1. The laboratory must establish criteria for evaluation of performance of

all personnel.
2. Training records must be maintained for all personnel. These should
include all job related formal trainings taken by the personnel which
pertains to any aspect of their responsibilities, including but not limited
to analytical methodology, laboratory safety, sampling, quality
assurance and data analysis.
3. The Head of the Laboratory must evaluate the performance of all
personnel as the need arises.

FACILITIES AND EQUIPMENT REQUIREMENTS

Floor Plan

A Screening Laboratory shall have at least twenty (20) square meters in floor
area. The work area must be ten (10) square meters with an exhaust fan, sink
and storage cabinet.

A Confirmatory Laboratory shall have at least sixty (60) square meters in floor
area. The clinical work area must be thirty (30) square meters with exhaust fan,
sink, fume hood, stock room and instrumentation room.

A laboratory of whatever category shall have within its premises an area, which
can receive or accommodate at least five (5) prospective Client/Donor/Subjects
at a time, a hand-washing facility, toilet facility, and stall for the orderly
collection of specimen.

A DOH-accredited hospital or non-hospital based Secondary or Tertiary Category

Clinical Laboratory which intends to put up a Screening Laboratory for Drug
Testing need not provide an additional twenty (20) square meters to its existing
floor area. It shall only designate an area for drug testing within the clinical
laboratory.

Equipment/Maintenance/Supplies and Materials

Collection Device
The collection device considered for the following types of specimen
collected:
Chapter .3

FACILITIES AND EQUIPMENT REQUIREMENTS

3.1 Floor plan

3.1.1 Screening Laboratory- shall have at least twenty (20) square meters in floor area. The work area must
be ten (10) square meters with an exhaust fat, sink, and storage cabinet.

3.1.2 Confirmatory Laboratory- shall have at least sixty (60) square meters in floor area. The clinical work
area must be thirty (30) square meters with exhaust fan, sink, fume hood, stock room and instrumental
room.

A laboratory of whatever category shall have within its premises an area, which can receive or
accommodate at least five (5) prospective Client/Donnor/Subjects at a given time, a hand washing facility,
toilet facility, and stall for the orderly collection of specimen.

A DOH-accredited hospital or non-hospital based Secondary or Tertiary Category Clinical

Laboratory which intends to put up a Screening Laboratory for Drug Testing need not provide an additional
twenty (20) square meters to its existing floor area. It shall only designate an area for drug testing within
the clinical laboratory.

Refer to Figures 2 and 3 (Prototype of Floor Plan).

3.2 Equipment/Maintenance/Supplies and Materials

3.2.1 Refer to Table 2, page 166

(Table to Technique/ Equipment/Glassware/Reagents/Supplies and Materials)

3.2.2 Collection Device

The collection device considered for the following types of specimen collected:

(a) For urine specimen: Screw capped, wide mouth, 30 or 60mL capacity polyethylene specimen
container.
(b) For scalp hair specimen: Self-sealing transparent plastic bag, 200 mg capacity.
(c) For oral fluid (saliva) specimen: Screw capped wide mouth 30mL capacity polyethylene
specimen container.
(d) For sweat specimen: patch placed on the skin and transferred in a container with suitable
transport medium.
(e) For blood: 10 ml capacity plain test tube.
(f) For tissue: specimen immediately frozen and transported placed in clean, dry, tightly capped
plastic container with no additives.
(g) For fingernails: Self-sealing transparent plastic bag, 200 mg capacity.

Note:
(i) The collection device shall not affect or alter the specimen collected.
(ii) All specimen containers shall be properly labeled and sealed.
(iii) If the collection device is unique and integral part of the collection and analytical testing
procedure, it must be registered by an appropriate agency designated by DOH as a medical device
(e.g., the sweat patch)
(iv) Single-use items are not unique collection devices and are not required to be cleared by the
DOH.

3.2.3 Calibration and Maintenance

Properly functioning equipment is essential for accurate testing. The equipment maintenance and
calibration record shall document that all instruments are properly maintained, calibrated, cleaned and
monitored.
3.2.3.1 All equipment must be calibrated and maintained according to the procedures in the manufacturer’s
manual.

3.2.3.2 There shall be a record indicating that the equipment has been calibrated and/ or checked on a
regular schedule based on established procedures.

3.2.3.3 Trained personnel should be assigned to calibrate equipment regularly.

3.2.3.4 Corrective actions and recommendations must likewise be documented when instruments fail to
function as expected.

3.2.3.5 Contents of calibration/maintenance record:

(a) Name of instruments, model, serial number;

(b) Name of accessory parts;
(c) Name and address of local distributor;
(d) Date and amount of purchase;
(e) Date of calibration;
(f) Date of malfunction;
(g) Date of repair/corrective action(s) taken;
(h) Recommendations; and
(i) Name of authorized person who performed the calibration/ maintenance of equipment.

3.3 Lighting and Ventilation

There shall be adequate lighting and ventilation in all work areas.

Chapter 4

COLLECTION SITE

There shall be a designated space or area for collection of specimen:

4.1 It shall be a designated area within the laboratory or a temporary facility located at a remote site.

4.2 The selection of an appropriate collection site will depend on the type of specimen being collected.

4.3 A collection site must have the following:

4.3.1 A suitable clean surface for handling the specimen and completing the required
paperwork;
4.3.2 A secured temporary storage capability to maintain a specimen until it is tested or shipped
to the laboratory.
4.3.3 An area to provide Client/Donor/Subject privacy appropriate to the specimen being
collected (e.g., toilet);
4.3.4 A controlled and secured area for supplied and records;
4.3.5 A poster or information bulletin with a detailed description of the proper specimen
collection processes.
4.3.6 A source of water for hand washing external to toilet facility (for urine collection)

4.4 Collection of specimen at a temporary/remote facility can only be conducted at the following
locations/conditions:
4.4.1 Workplace/school/jail or prison/ rehabilitation center for:
4.4.1.1 Random
4.4.1.2 Follow-up
 4.4.1.3 Reasonable suspicion/cause
4.4.1.4 Crime scene and post accident
4.4.2 Person who are critically ill/disabled
4.5 Collection of specimen for all mandatory drug testing (e.g., driver’s license, R.A. 9165) shall
be done at a permanent facility except for crime scene and post accident.
4.6 The DTL must secure a permit from BHFS/CHD ten (10) working days prior to the scheduled
activity except crime scene/post accident. The secured permit must be kept confidential
among drug testing laboratories, requesting party and BHFS/CHD. Failure to secure a permit
will be dealt with accordingly.
4.7 No examinations must be conducted at a temporary collection facility.

Note: Refer to Appendix J (BHFS Bureau Circular No. 09 s. 2003 re: Guidelines for Remote Collection for
Drug Testing Specimen)

Chapter 5
 SPECIMEN

The NRL shall evaluate the protocol for each type of specimen.

5.1 Types of Specimen

A Drug Testing Laboratory may collect:

5.1.1 Blood
5.1.2 Fingernails
5.1.3 Saliva (oral fluid)
5.1.4 Scalp Hair
5.1.5 Sweat (Patch)
5.1.6 Tissue
5.1.7 Urine

5.2 Reason for Test

5.2.1 Blood : Reasonable suspicion/ cause
5.2.2 Fingernails : reasonable suspicion/ cause
5.2.3 Scalp Hair : Pre-employment, random, return to
duty, follow up
5.2.4 Saliva (Oral Fluid) : Pre-employment, random, reasonable
suspicion/cause
5.2.5 Sweat (patch) : Return to duty, follow up
5.2.6 Tissues : Reasonable suspicion/cause
5.2.7 Urine : Pre-employment, random, reasonable
suspicion/cause, mandatory
5.3 More than one type of specimen maybe collected at same time from the same Client/ Donor/
Subject.

5.4 A specimen may be tested for other purposes provided that the quality of the specimen for
which it will be tested is maintained and the chain of custody is intact.

5.5 The minimum quantity of specimen to be collected:

5.5.1 Blood : Minimum of 5 mL

5.5.2 Fingernails : To be determined
5.5.3 Scalp Hair : 100 mg hair (or its equivalent in number
of strands or 1 cm. Abov the scalp)
5.5.4 Tissue : To be determined
5.5.5 Saliva (Oral Fluid) : 2 ml collected as a “neat” specimen
(divided as follows: at least 1.5 mL the
primary specimen and at least 0.5 mL for the
challenge test)

5.5.6 Sweat : 1 “patch” worn for 7 to 14 days

5.5.7 Urine : 60mL in single container or 30 mL each
in two separate containers for split
specimen.

Note:
(I) The type and quantity of specimen listed above may vary depending on the
existing technology.
(II) Specimen may be collected using single container, however, split specimen
collection maybe done upon request if situation permits.
 5.6 Handling and Storage

Proper handling and storage of specimen must be taken to ensure the integrity of the drug
and/or metabolite.

5.6.1 Blood : separate serum then immediately freeze

specimen
5.6.2 Fingernails : to be determined
5.6.3 Scalp hair : stored at cool and dry place
5.6.4 Tissue : macerated and frozen.
5.6.5 Saliva : deep-frozen at least- 8 to 10OC
5.6.6 Sweat : to be determined
5.6.7 Urine ; prolonged storage at –20OC

Note: Urine maybe stored initially in the refrigerator between 2-6OC, for not more than 1 day.

5.7 Transport

Specimen must be properly labeled, sealed and placed in a cooler with dry ice or a suitable
alternative. The following must be observed in its transport:

5.7.1 Minimize the number of personnel handling the specimen.

5.7.2 Document the date and the purpose on the CCF each time a specimen is handled or
transferred. Identify each person who handled the specimen. When courier services are
utilized, the time of receipt from the collection site and the time of delivery to the
laboratory must be documented on the CCF.
5.7.3 Place specimen in sealed transparent plastic bag and an appropriate transport container
designed to minimized damage, and seal them securely to eliminate the possibilities of
tampering.
5.7.4 Ensure that the CCF accompanies the appropriate specimen transport container.
5.7.5 Mail or deliver the specimen to the testing laboratory. The transport of samples shall be
accomplished while maintaining adequate specimen validity if a commercial courier or
postal service is used. If a staff member delivers the specimen, the laboratory must
record and report any apparent tampering with the container or specimen, any
discrepancy in the specimen and the CCF.
 Chapter 6

LABORATORY PROCEDURE FOR SPECIMEN HANDLING

A DOH- accredited laboratory must have a standard operating procedure (SOP) manual that
describes, in detail, all laboratory operations pertaining to specimen handling. When followed, it
ensures that all specimen are tested using the same procedure and in a consistent manner.

6.1 Observed Specimen Collection for Urine

Observed samples are collected in the presence of the Authorized Specimen Collector.

6.1.1 The Preliminary procedures for specimen collection.

The Authorized Specimen Collector shall:

6.1.1.1 Prepare and secure all collection supplies, materials and record
6.1.1.2 Verify the Client/Donor/Subject’s identification
6.1.1.3 Explain the basic collection procedure to the Client/Donor/Subject;
6.1.1.4 Answer any reasonable and appropriate questions the Client/Donor/Subject may
ask regarding the collection procedure.
6.1.2 Basic steps in collecting urine specimen for drug testing:

6.1.2.1 The Client/Donor/Subject removes all unnecessary outer garments (such as coat
or jacket), after which, he/she will be subjected to a bodily search.
6.1.2.2 The Authorized Specimen Collector directs the Client/Donor/Subject to empty
his/her pockets and checks items that may be used to adulterate the specimen.
6.1.2.3 The Authorized Specimen Collector either gives or allows the Client/
Donor/Subject washes and dries hands prior to collection. After washing hands,
the Client/Donor/Subject must remain in the presence of the Authorized
Specimen Collector and must not have access to anything that could be used to
affect the specimen.
6.1.2.4 The Authorized Specimen Collector either gives or allows the
Client/Donor/Subject to select the collection container from available supplies.
The specimen container is opened in full view of the Client/Donor/ Subject.
6.1.2.5 The Authorized Specimen Collector directs the Client/Donor/Subject to go in the
toilet facility for urination and to provide at least 60-mL either collected in singe
or split specimen.
6.1.2.6 The Authorized Specimen Collector shall observe closely the entire collection
procedure and take note of the conduct and demeanor of Client /Donor/Subject
for attempts of substitution, adulteration and dilution of specimen.
 6.1.2.7 A tampered specimen is sent to the laboratory for validity testing and the
Authorized Specimen Collector shall document the tampering on the CCF with
appropriate remarks. The authorized Specimen Collector shall instruct the
client/Donor/Subject to provide another urine specimen immediately, under
direct observed collection. This second specimen shall also be sent for
examination.
6.1.2.8 After the client/Donor/Subject hands the specimen, the authorized Specimen
Collector must measure the temperature, check volume and inspect its physical
characteristics.
6.1.2.9 The Authorized Specimen Collector and Client/Donor/Subject must keep the
specimen in full view at all times prior to sealing of all specimen containers.
6.1.2.10 A tamper-evident label/seal must be used to secure the entire specimen
container.
6.1.2.11 Both Authorized Specimen Collector and Client/Donor/Subject must affix their
signature on the seal together with the date and time of collection
6.1.2.12 The Authorized Specimen Collector must complete steps 1 and 2 and initiates
step 4 of CCF.
6.1.2.13 The Client/Donor/Donor/Subject must affix his/her signature at Step 5 of the
CCF. The Authorized Specimen Collector may ask the Client/Donor/Subject to
list any prescription, medication he/she may have taken for the past two weeks
at the back of the CCF (Analyst copy). Authorized Specimen Collector shall
distribute each copy as required.
6.1.2.14 In case of specimen collection at a remote site and transport via a courier/mail,
the specimen container together with the CCF shall be placed in a sealed,
labeled and secured transparent plastic bag.

Note: Protocol for collection for other types of specimen shall be determined in a later publication.

6.1.3 Visual privacy requirements when collecting a specimen

6.1.3.1 For urine specimen:

A laboratory must have the required restroom/stall with a toilet for the
Client/Donor/ Subject to have privacy while collecting the urine specimen.

6.1.3.2 For scalp hair specimen:

The Authorized Specimen Collector shall collect available scalp hair 1 cm.
above the scalp from the Client/Donor/Subject at a designated area.

6.1.3.3 For sweat specimen:

The sweat patch is applied to the Client/Donor/Subject’s upper arm, chest, or

back and removed by the authorized Specimen Collector at a designated area.

6.1.3.4 For blood specimen:

At least 5mL whole blood is extracted from Client/Donor/Subject placed in a 10-

ml capacity test tube without anticoagulant at a designated area.

6.1.3.5 For saliva (oral fluid) tissue/fingernails specimen:

The “neat” saliva (oral fluid)/tissue/fingernails specimen is collected directly

into an appropriate container by the Client/Doner/Subject under the direct
observation of the Authorized Specimen Collector at a designated area.
6.2 Unobserved Specimen Collection:

Unobserved samples are collected in the absence of Authorized Specimen Collector or

submitted samples that are not collected at the collection site or laboratory. Unobserved
samples are subject to specimen validity test.

Conditions when unobserved specimen collection is allowed. When Client/Donor/Subject is:

6.2.1 Physically unable to go to the laboratory or designated collection site

6.2.2 Involved in crime scene
6.2.3 Involved in post-accident
6.2.4 Critically ill

6.3 Integrity of Urine Specimen

The Authorized Specimen Collector must adopt procedures to minimize the risk of
adulteration, substitution or dilution of the specimen during the collection procedure. The
following precautions shall be taken to ensure the integrity of the specimen.

6.3.1 To deter the dilution of specimen at the collection site, toilet water coloring agents should
be placed in toilet tanks or in the toilet bowl. Any other sources of water in the enclosure
where urination occurs (e.g., taps, shower) will be secured prior to collection.

6.3.2 The Authorized Specimen Collector will ask Client/Donor/Subject to remove any
unnecessary outer garments such as a coat or jackets that might conceal items or
substances that could be used to tamper with or adulterate the Client/Donor/Subject’s
urine specimen. He/she shall be subjected to bodily search. The Authorized Specimen
Collector will ensure that all persona belongings such as purse of briefcase remain with
the outer garments.

6.3.3 The Client/Donor/Subjects will be instructed to was and dry his/her hands prior to
urination. After washing hands, the Client/Donor/Subject will remain in the presence of
an Authorized Specimen Collector and will not have access to any unregulated source of
water, soap dispenser, cleaning agent, or any other materials that could be used to
adulterate the specimen.

6.3.4 The Authorized Specimen Collector will give or the Client/Donor/Subject will choose a
clean specimen container from the available supplies. The Client/Donor/Subject may
provide his/her specimen in the privacy of a toilet cubicle or otherwise partitioned area
that allows for individual privacy. The Client/Donor/Subject will be instructed not to
flush the toilet until the specimen is handed to the Authorized Specimen Collector.

6.3.5 Upon receiving the specimen from the Client/Donor/Subject, the Authorized Specimen
Collector will:

6.3.5.1 Check the volume of urine in the specimen container

6.3.5.2 Check the temperature of the urine specimen.
6.3.5.3 Inspect the specimen to determine its color and appearance for any signs of
contaminants. Any unusual findings will be noted on the Custody and Control
Form.

6.3.6 Both the Client/Donor/Subject and the Authorized Specimen Collector will keep the
specimen container/specimen bottles in view at all times prior to the urine specimen
being sealed and labeled.
6.3.6.1 The specimen bottle will have an identification label that contains pertinent
information such as date and time of specimen collection, signatures of the
 donor/client/subject and Authorized Specimen Collector and specimen ID
number.
6.3.6.2 The Authorized Specimen Collector will fill-up steps 1 and 2 initiates step 4 of
the Custody and Control Form and pack together with the urine specimen
immediately for dispatch to the analytical laboratory.

6.4 Specimen rejection and cancellation of tests

All rejected specimen should be reported to the Head of the Laboratory stating the reason(s) or
rejection.

6.4.1 Criteria for specimen rejection that are non-correctable

6.4.1.1 Incompatibility of the ID number on the specimen received by the laboratory

with the number on the CCF
6.4.1.2 Absence of ID number on the specimen
6.4.1.3 No printed Authorized Specimen Collector name and signature on the CCF
6.4.1.4 Broken or tampered seal on the specimen container
6.4.1.5 Insufficient quantity of specimen.

6.4.2 Criteria of specimen rejection that is correctable

6.4.2.1 Failure of the Authorized Specimen Collector to sign CCF.

6.4.2.2 Failure to check and record the specimen temperature with appropriate remarks.

6.4.3 Appropriate remedial measures for correctable errors:

6.4.3.1 All errors must be properly documented, recorded in a memorandum for Record
(MFR) and duly signed by the Authorized Specimen Collector.
6.4.3.2 If the Authorized Specimen Collector’s signature cannot be corrected by a
Memorandum For Record (MFR), the laboratory must repost the specimen
rejected for testing and provide a reason on the report.
6.4.3.3 If the Authorized Specimen Collector cannot provide an MFR to attest to the
fact he or she did measure the specimen temperature, the laboratory may report
the test results for the specimen but indicate that the Authorized Specimen
Collector could not provide an MFR to recover the omission.

6.5.4 Conditions that will not cause specimen rejection or cancellation of test

6.5.4.1 At the receiving area:

(a) Discrepancies of the laboratory name and address;

(b) Incomplete/incorrect/unreadable employer name or address’
(c) Name of the head of the laboratory is not indicated
(d) Incomplete/incorrect address of the Head of the Laboratory;
(e) Incorrect entry of the Client/Donor/Subject’s ID number
(f) Unmarked “reason for test” box;
(g) Unmarked “drug tests to be performed” box;
(h) The collection site address is not indicated;
(i) Unmarked “specimen collection” box;
(j) Unmarked “observed” box (if applicable);
(k) The date and time of collection is not indicated
(l) Incorrect entry of name of delivery/courier service; or
(m) The Client/Donor/Subject’s name inadvertently appears on the laboratory copy of the
CCF or on the tamper-evident labels used to seal the specimen bottles.

6.5.4.2 Within the laboratory:

 (a) Failure to print and sign the accessioner’s name;
(b) Failure to print and sign the Analyst’ name;
(c) The Analyst accidentally initials the CCF rather than providing a signature for a non-
negative result (Analyt’s initials are acceptable for a negative result);
(d) The accessioner fails to mark one of the “primary specimen bottle seal intact” boxes, but
the laboratory reported a “rejected for testing” result with an appropriate comments on
the “Remarks” line.

Note: The above errors, omissions, and discrepancies are considered insignificant only when they occur
less than one percent of the time. The expectation is that each trained Authorized Specimen Collector and
accredited laboratory will make every effort to ensure that the CCF is properly completed and that all the
information is correct. When an error occurs more than one percent of the time, the Head of the Laboratory
must direct the Authorizes Specimen Collector or laboratory personnel (whichever is responsible for the
error) to immediately take corrective actions to prevent the recurrence of the error.

6.5.4.3 Situation / error that may require the Head of the Laboratory to cancel a test

(a) The client/ Donor/Subject’s signature is missing on the Laboratory copy of the CCF and
the Authorized Specimen Collector failed to provide a comment that the Client /
Donor /Subject refused to sign the form;
(b) The analyst failed to sign the CCF for a specimen being reported drug positive,
adulterated, substituted, rejected for testing, or invalid test result; or
(c) The electronic report provided by the laboratory does not contain all the data elements
required for the DOH standard electronic laboratory report for a specimen being reported
drug positive, substituted, rejected for testing, or invalid test result.

6.5.4.4 Corrective measures that the Head of the Laboratory must do prior to cancellation of the test
in the above situation

(a) The Head of the laboratory must contact the Authorized Specimen Collector to obtain a
statement to verify that the Client/Donor/Subject refused to sign the Laboratory copy. If the
Authorized Specimen Collector cannot provide such a statement, the Head of the Laboratory
must cancel the test.
(b) The Head of the Laboratory must obtain a statement from the Analyst that he or she
inadvertently forgot to sign the CCF, but did, in fact, properly conduct the certification
review.
(c) The Head of the Laboratory must require the laboratory to modify and retransmit a corrected
electronic report.

6.5.5 Conditions for retention of specimen

6.5.5.1 A laboratory must retain a specimen that was reported as negative for a minimum of
five days after receipt of result.
6.5.5.2 A laboratory must retain a specimen that was reported either as positive, adulterated,
substituted, or invalid result for a minimum of 15 days upon receipt of the result. A
specimen may be retained for a maximum of 1-year upon request. If no such request
is received, a specimen may be discarded.
6.5.5.3 A retained specimen must be kept in a second location appropriately, to ensure its
availability for any necessary retesting during an administrative or judicial
proceeding.

6.6 Tests for additional drugs

Specimen can be tested for additional drugs upon request, depending on the service capability of
the drug-testing laboratory. However, when a laboratory performs a procedure to test specimen for
 which it is not accreted, it must inform the Client/Donor/Subject that the specimen is not being tested
under the Guidelines and the procedures are not subject to review by the NRL.

Chapter 7

LABORATORY SECURITY AND CHAIN OF CUSTODY

The laboratory must provide an outline regarding chain-of-custody procedures during

accessioning/receiving, aliquoting, initial and confirmatory testing, and disposition of specimen and
aliquots consistent with the laboratory’s actual procedures.

7.1 Chain of Custody

7.1.1 Drug Testing Custody and Control Forms

7.1.1.1 Bureau of Health Facilities Services (BHFS) approved Drug Testing Custody
and Control Form (CCF) must be used to document the collection of a specimen
by all drug-testing laboratories.
7.1.1.2 The form is used to document chain of custody from the time a
Client/Donor/Subject gives the specimen to the Authorized Specimen Collector
until the specimen is received for testing.
7.1.1.3 The CCF used for each type of specimen collected should be available at the
drug testing laboratories. A sample of the BHFS-CCF for each type of specimen
is available at the following website: www.doh.gov.ph

7.2 Accessioning

The laboratory must:

7.2.1 Provide a unique accession number upon entry of the specimen to the laboratory;
7.2.2 Inspect the specimen submitted and the CCF to verify the integrity and identity of the
specimen;
7.2.3 Examine the packaging for evidence of tampering in transit;
7.2.4 Compare the information on the sample bottles within the package
7.2.5 Document all discrepancies

7.3 Security Measures

7.3.1 A laboratory must control access of unauthorized individual and ensure that no
unauthorized individual can gain access to specimen, aliquots, or records.
7.3.2 All authorized visitors must be escorted at all times.
7.3.3 A laboratory must maintain a record that documents the dates, time of entry and exit, and
purpose of entry of authorized escorted visitors accessing secured areas.

Chapter 8

ANALYTICAL METHODS

8.1 Techniques
8.1.1 Screening
8.1.1.1 Immunoassay

These methods are used for preliminary screenilg (i.e., initial screening), based on an
antibodq-antigen reaction. Small amounts of the drug and/or metabolite (s) may be detected.
The following are examples of this technique:

(a) Enzyme immunoassay (EIA)

 (b) Enzyme-mudtiple immunoassay techniaue (EMIT)
(c) Fluorescence polarization
(d) Radioimmunoassay (RIA!

8.1.1.2 Chromatography

Separation of a mixture is the main outcome of the ahromatographic method. In this process,
a mixture of substances is separated in a stationarx medium. The types of chromatographic
processes are:

(a) Thin Layer Chromatography (TLC)

(b) Gas Chromatography (GC)
(c) Liquid Chromatography (e.g., HPLC)
8.1.2 Confirmatory

8.1.2. Hyphenated technique – combination of two sophisticated technologies (e.g.,- GC-MS)

or other such modern and acceptable technique (e.g., LC-MS, GC)MS-MS or LC-MS-
MS).

8.2 Test
8.2.1 Screenifg Laboratory
8.2.1.1 A laboratory that performs a validated test to differentiate negative specimen from a specimen
that requires further testing for drugs and/or metabolite.
8.2.1.2 The method used may be;

(a) A registered testing kits approved by the DOH

(b) Instrumented screeni.g method

8.2.1.3.1 A screenilg laboratory may conduct a repeat screening test on the same sample prior to the
confirmatory test.

8.2.1.4 The screening laboratory must submit all samplds with posidive results to any DOH
accredited confirmatory drug testing laborator9. Together with the sample, thd following
documents shall be submitted.:

(a) Accomplished Custody and Control Form

(b) Initial Laboratory Report
(c) Letter Request for Confirmatory Test

8.2.1.5 The release of the results will be dependent on the:

(a) Availability of confirmatory laboratory
(b) Distance of cmnfirmatory laboratory from the Screening laboratory

8.2.1.6 The screening haboratory must jeep specimen wath a negative result for a minimum of 5 days
upon receipt of result. In c`se the result is not retrieved by the Client/Donor/Subject the
laboratory has the option to discard the specimen after 5 days.

8.2.2 Confirmatory Laboratory

8.2.2.1 A laboratory that performs a confirmatory analysis using validated analytical procedure by
NRL of an aliquot of specimen submitted from a screening laboratory in order to identify and
quantify the presence of a metabolite.
8.2.2.2 The procedure used must combine chromatographic separation and mass spectrometric
identification in the same procedure (e.g., GC/MS, LC/MS/MS or LC/MS/MS)
8.2.2.3 All confirmatory laboratories must accept specimen tested positive from a screening
laboratory with accompanying request for confirmatory testing and previous result of
analysis.
8.2.2.4 Confirmatory laboratory must keep the remaining specimen tested positive. Only the results
of the confirmatory test will be given to the screening laboratory.
8.2.2.5 The confirmatory laboratory must release within three (3) to five (5) working days upon
receipt of the specimen depending on workload and availability of equipment and supplies.
For criminal case-related drug testing, the confirmatory result should be released 24 houró
after submission of specimen. In case, the test cannot be done, notify the requesting party to
refer to another confirmqtory laboratory.

Chapter 9

URINE SPECIMEN VALIDITY TEST

A validity test is a test to determine the integrity of the specimen.

9.1 Validity procedures for unobserved urine collection to determine the integrity ïf`the specimen.

9.1.1 Perform initial validity tests.

9.1.1.1 Urine(physical examination in the followyng conditions:

(a) Temperature
(b) Abnormal physical appearance (e.g., color, odor, excessive foaming);
(c) Reactions or responses characteristics of an adulterant obtained during initial or confirmatory
drug tests (e.g., non-recovery of standards, unusual response); or
(d) Possible unidentified interfering substance or adulterant. The choice of additional validity
tests is dependent on the observed indicators or characteristics as described in a (a) (b).

9.1.1.2 Urine specific gravity, pH and nitrites;

9.1.1.3 Urine creatinine concentration;
9.1.1.4 Validity test(s) for presence of oxidizing adulterants as needed.

9.1.2 Perform confirmatory validity tests using other procedures, instruments and/or methods on the
same sample.

Notes:

i) All unobserved samples for validity testing shall be submitted to an accredited

drug testing facility with at least secondary clinical laboratory capability.
ii) Validity tests for other types of specimen shall be incorporated for future
reference.

9.2 Criteria for determining urine specimen

9.2.1 Invalid:

A urine specimen is invalid when:

9.2.1.1 Adulterated, substituted and diluted;

9.2.1.2 Improperly collected, handled and stored; and
9.2.1.3 Improperly documented.
9.2.2 Adulterated:

9.2.2.1 The nitrite concentration is confirmed to be greater than or equal to 500 ug/dL;
9.2.2.2 The pH is less than 3 or greater than or equal to 11;
9.2.2.3 The specimen contains an exogenous substance (i.e., a substance which is not a normal
constituent of urine); or
9.2.2.4 The specimen contains an endogenous substance at a concentration greater than what is
considered a normal physiological concentration

9.2.3 Substituted:

A urine specimen is reported substituted for non-human urine specimen when both the initial and
confirmatory specific gravity tests have the following results:

9.2.3.1 The creatinine concentration is less than 442.0 umol/L; and

9.2.3.2 Specific gravity is less than 1.002 or greater than or equal to 1.020.

9.2.4 Diluted:

A urine specimen is reported dilute when the initial or confirmatory test have creatinine and
specific gravity results of:

9.2.4.1 The creatinine concentration is less than 1768.0umol/L;

9.2.4.2 The specific gravity is less than 1.003; and
9.2.4.3 The creatinine and specific gravity results do not meet the criteria for a substituted or invalid
result.

9.3 Procedures for conducting each validity test on a urine specimen

9.3.1 For creatinine concentration:

9.3.1.1 The creatinine concentration shall be measured to one decimal place on both the initial test
and the confirmatory tests;
9.3.1.2 The initial creatinine test shall have a calibrator at either 442.0umol/L or at 1768.0umol/L;
9.3.1.3 The initial creatinine test shall have a control in the range of 176.8 umol/L to 353.6umol/L, a
control in the range of 442.0umol/L to 1786.0umol/L, and a control in the range of
1856.4umol/L to 2210.0umol/L;
9.3.1.4 The confirmatory creatinine test (performed on that specimen with a creatinine concentration
less than 442.0umol/L on the initial tests) shall have a calibrator at 442.0umol/L or at
1768.0umol/L,a control in the range of 176.8umol/L to 353.6umol/L, and a control in the
range of 530.4umol/L to 707.2 umol/L.
9.3.2 For specific gravity:

9.3.2.1 The specific shall be measured using a refractometer on both initial and confirmatory tests.
The refractometer shall be capable of reading in increments of at least 0.001 or less.
9.3.2.2 The initial and confirmatory specific gravity tests shall have a calibrator at 1.000
9.3.2.3 The initial and confirmatory specific gravity tests shall have the following controls:

(a) For the cutoff less than 1.002, one control at 1.001 and one control in the range of
1.002 to 1.010.
(b) For the cutoff of greater than or equal to 1.020, one control greater than or equal to
1.020 but not greater than 1.025, and one control in the range of 1.015 to 1.020.

9.3.3 For pH:

9.3.3.1 Dipstick, pH paper or spectrometric/colorimetric tests may be used for initial validity test.
9.3.3.2 A pH meter shall be used to perform confirmatory validity test.
9.3.3.3 The initial and confirmatory pH meter tests shall have the following controls:

(a) For the cutoff of less than 3, one control in the range of 2 to 2.9 and one control in the range
of 3.1 to 4.
(b) For the cutoff of greater than or equal to 11, one control in the range of 10 to 10.9 and one
control in the range of 11.1 to 12.
(c) Spectrometric/colorimetric initial pH tests shall have the following controls;

(i) For the cutoff of less than 3, one control in the range of 2 to 2.9.
(ii) For the cutoff of greater than or equal to 11, one control in the range of 11.1 to 12.

9.3.4 For oxidizing adulterant tests:

9.3.4.1 At a minimum, the initial test(s) for oxidizing adulterants shall be capable of detecting
nitrites, chromates, and halogens (e.g., bleach, iodine). The detection of these adulterants
may be achieved by using either a general oxidizing adulterant tests or by using specific tests
for each category of these adulterants. If an initial test for oxidizing adulterants
simultaneously tests for all oxidizing adulterants, the assay shall be able to detect at least the
activity equivalent to 20mcg/mL of chromate (chromium VI) or 200 mg/dL of nitrites as an
LOD. Each analytical run of specimen shall include a control without the compound of
interest (ie. Accredited negative control) and at least one positive control with one of the
compounds of interest at a concentration, which exhibits an oxidizing activity above the
documented LOD of the procedure.
9.3.4.2 A confirmatory test for a specific oxidizing adulterant shall use a different analytical principle
or chemical reaction than that used for the initial test unless a recognized reference method is
used for both the initial and confirmatory tests. Each analytical run of specimen shall include
a control without the compound of interest (i.e., accredited negative control) and a positive
control with the compound of interest at a concentration above the documented LOD of the
procedure.

9.3.5 For nitrite concentration:

9.3.5.1 Dipsticks may only be used to determine if initial and confirmatory nitrite tests shall be
performed.
9.3.5.2 A nitrite specific initial test shall have a calibrator at the cutoff concentration, a negative
control (ie., accredited negative urine), one control in the range of 200 mcg/ml. To 500
mcg/mL., and one control in the range of 500 mcg/ml/ to 625 mcg/ml.
9.3.5.3 The confirmatory nitrite test shall have a calibrator at the cutoff concentration, a negative
control (i.e., accredited negative urine), one control in the range of 200 mcg/ml to 500
mcg/ml., and one control in the range of 500mcg/ml. to 625mcg/ml.

9.3.6 For other validity tests (e.g., glutaraldehyde, surfactants):

9.3.6.1 Each analytical run of specimen shall include a control without the compound of interest (i.e.,
a negative control) an a positive control with the compound of interest at a concentration
above the documented LOD of the procedure.
9.3.6.2 A confirmatory test for a specific adulterant shall use a different analytical principle or
chemical reaction than that used for the initial test unless a recognized reference method is
used for both the initial and confirmatory tests.
9.3.6.3 The initial and confirmatory tests for anionic surfactants shall be able to detect at least the
activity equivalent to 100 mcg/ml of dodecylbenzene sulfonate.

Note: Deviations on the above numerical values may vary depending on the prevailing technology,
procedure and reference materials used by the laboratory.
 Chapter 10

RECORDING

The laboratory shall develop and maintain clear and well-documented records detailing procedures for
collection, accessioning, result of analysis and remedial measures, which shall not be limited to the
following:

10.1 Chain of Custody

Chain of Custody (COC) records must reflect the actual chain of custody procedures 9e.g., the
movement between individuals or movement to /from temporary storage) that are used for handling
specimen.

10.2 Memorandum for Records (MFR)

It is a record to document specimen that had been rejected or cancelled. In includes reason and
corrective measures done.

10.3 Results of Analysis

Records for all screening/confirmatory test result and /or of the documents contain the following:

10.3.1 Test results

10.3.2 Test results of control/calibrator/standard
10.3.3 Laboratory identification of specimen tested
10.3.4 Identification of individual performing and reviewing the test results.
10.3.5 Evidence of review by the certifying Analyst in confirmatory tests
10.3.6 Evidence of confirmatory work sheets or other review documents of comparison of the initial and
confirmatory testing data to ensure consistent results.
10.3.7 Strikeout changes made on tests results and other records must be properly annotated by the
responsible individual.

10.4 Inventory of reagent, supplies and materials.

There must be a record of all reagents, supplies and materials used.

10.5 Equipment, maintenance and repair record

The equipment, maintenance and repair record should document that all instruments are properly
maintained, calibrated, cleaned and monitored including the corrective measures and
recommendations done.

10.6 Storage of collection site records

Collection site records must be stored for a minimum of 2 years in the laboratory or as required by
law.

10.7 Quality Assurance Program Record

10.7.1 Internal quality control

10.7.2 External quality control
10.8 Storage of laboratory records

10.8.1 A laboratory must retain all records generated to support test results for at least 2 years.
10.8.2 However, all other records associated with positive results or a particular specimen under legal
challenge shall be maintained for an indefinite period.

10.9 Electronic storage system

10.9.1 A DOH-accredited laboratory shall store and archive all record electronically to duly authorized
application service provider.
10.9.2 The laboratory must validate that the method used to create the electronic records provides an
accurate representation of the original records.
10.9.3 The method used to create the electronic records must prevent the alteration of any stored
information and/or data.
10.9.4 The method used must allow easy retrieval an reproduction of the original records.
10.9.5 The laboratory shall assure the integrity of data electronically stored under its information
technology facilities without prejudice to pertinent statutes on privacy/confidentiality and
transparency.
10.9.6 The laboratory shall assure the integrity of data by transmitting it electronically from their facility
to DOH within the prescribed time and measures to counter disruption of transmitted are installed
10.9.7 The laboratory shall assure that the data stored electronically have back-up copies for the purpose
of audit by the DOH and as a measure to preclude inadvertent of records.
10.9.8 Electronic transmittal of drug testing results shall be coursed by the DOH authorized application
service provider.

Chapter 11

REPORTING

The laboratory shall maintain specimen test results supported by data ad are reported in
accordance with the following written guidelines.

Procedure must be in placed to ensure confidentiality of records.

11.1 Guidelines for reporting a laboratory result.

11.1.1 All specimen submitted shall have a corresponding laboratory result issued within 15 days.
11.1.2 A positive screening result shall be subjected to confirmatory analysis. The final report shall be
based on the confirmatory results.
11.1.3 The screening laboratory shall be the only authorize laboratory to release the final report.
11.1.4 All laboratory reports of a screening laboratory shall bear the signature of the Analyst and Head of
the Laboratory. For a confirmatory laboratory, the reports shall bear the signatures of the Analyst,
Chief Chemist and Head of the Laboratory.
11.1.5 All confirmatory drug tests results should specify the concentration of the limit of detection
(LOD) of the method of the drug or metabolites. However, for clinical or therapeutic purposes,
the concentration shall be quantified.
11.1.6 A laboratory shall report all tests results using the DOH standard electronic laboratory report form.
The electronic report must be transmitted in a manner that ensures the confidentiality and security
of the information.
11.1.7 Reports for an adulterated or substituted test result must be based on an initial and confirmatory
validity test.
11.1.8 The laboratmry must report the specific validity test result(s) for a specimen that is reported
adulterated or substituted.
11.1.9 No result can b% relayed dhrough telephkne.

11.2 Statistical summary of the laboratory report.

11.2.1 A haboratory must submit annually to the BHFS a report containing the following:
11.2.1.1 Total number of specimen received and examined as classified according to:

(a) Mandatory
(b) Random
(c) Other reasons

11.2.1.2 The number of specimen that were reported as:

(a) Positive for each drug (listed separately)

(b) Adulterated
(c) Substituted
(d) Rejected for Testing
(e) Invalid result

11.2.1.3 The number of specimen sent for confirmatory testing (for screening laboratory).
11.2.2 The report must be submitted to the BHFS by mail, fax or email within 10 working days after the
end of the year.

11.3 Reviewing a positive, adulterated, substituted, or invalid test result

Prior to making a final decision on a specimen that was reported positive, adulterated, substituted,
or an invalid test result by the laboratory, the Head of the Laboratory shall:

11.3.1 Allow the Client/Donor/Subject to explain any circumstances leading to the test result.
11.3.2 Evaluate alternative medical explanations for the positive, adulterated, substituted, or invalid test
results.
11.3.3 Review current medical explanations for the positive, adulterated, substituted, or invalid test
result.

11.4 When the laboratory reports an invalid result due to the possible presence of an unidentified
interfering substance/adulterant, the Head of the Laboratory shall;
11.4.1 Send the specimen to another DOH accredited laboratory capable of identifying the interfering
substances/adulterant;
11.4.2 Report the result as “Test Cancelled” if the explanation provided by the Client/Donor/Subject is:

(a) Acceptable then an immediate direct observed collection is not required

(b) Not acceptable then an immediate direct observed collection is required.

11.5 For verification, the Client/Donor/Subject may obtain other documents.

The Client/Donor/Subject must submit a written request addressed to the head of the drug t%sding
laboratoby to obtain a cerpified true copy of COC and pertinent analytical data.
 Chapter 12

QUALITY ASSURANCE PROGRAM

12.1 Internal Quality Assuranbe Program (IQAP)

12.1.1 Screening Laboratory

12.1.2 Validation of a ccreening drug test

(a) The laboratory must demonstrated and document:

(i) The ability to differentiate positive and negative samples;

(ii) The performance of the test around the cut-off concentration; and
(iii) The performance of the test results at several concentrations between 0 to 150 percent of the
cutoff concentration

(b) Performance characteristics of new lots of testing kits must be evaluated prior to its use.

12.1.2.1 Batch quality control requirements when conducting a screening drug testing.

(a) For kits only

Each batch for specimen must contain the following types of QC samples:

(i) At least one control registered and validated by the DOH to contain no drug metabolite;
(ii) At least one control that has the concentration of the drug or metabolite at 25 percent above the
cutoff concentration; and
(iii) At least one control that has concentration of the drug or metabolite at 25 percent below the
cutoff concentration.

(a) Instrumented

(i) Each batch of specimen must contain the types of QC sample as in drug testing laboratory using
kits.
(ii) At least 10 batch must be calibrators and controls
(iii) A laboratory must document that any carryover that might occur between
aliquots during the initial testing is detectable and corrected.

12.1.3 Confirmatory Laboratory

12.1.3.1 Validation of a confirmatory drug test

The laboratory must demonstrate and document:

. (a) The linear range of the analysis;
(b) The limit of detection (LOD)
(c) The limit of quantitation (LOQ)
(d) The accuracy and precision at the cutoff concetration;
(e) The accuracy and precision at 40 percent of the cutoff concentration; and
(f) The potential for interfering substances.

12.1.3.2 Internal quality control requirements when conducting a confirmatory drug test.

(a) Each batch of specimen must contain, at a minimum, the following types of QC
samples:

(i) A three-point calibrator at the cutoff;

(ii) At least one negative control;
 (iii) At least one positive control within 25 percent above the cutoff concentration;
and
(iv) At least one blind control in every batch.

(b) At least 10 percent of each batch must be calibrators and controls.

(C) On a re-test/re-confirmation challenge, the batch must have one control that has the
concentration of the drug or metabolite at or below 40 percent of the cutoff concentration
(d) The linear range, limit of detection, and limit of quantitation must be documented and
periodically re-evaluated for each confirmatory drug test.
(e) A laboratory must document that any carryover that might occur between
aliquots/extracts in the confirmatory batch is detectable and corrected

12.1.4 Analytical and quality control requirements for performing urine specimen validity tests

12.1.4.1 A validity test result for a specimen shall be bised on performing an initial (first)
validity test on one aliquot and a confirmatory (second) validity test on a second
iliquot. In some cases, roth validity tests may use the same procedure,
instruments, and/ or method.
12.1.4.2 The performance characteristics (e.g., accuracy, precision, LOD, LOQ, linearity,
specificity) shall be documented for eaci"validity test as appropriate
12.1.4.3 The LOD of suspected adulterants shall be determined
12.1.4.4 Each analytical run of specimen"for which an initial or confirmatory validity test
is being performed shall include the appropriate calibrators and controls.

12.1.5 Blind Samples Submitted by a Drug Testing Laboratory

(a) A blind sample must be validated as to its content by the suppler using initial and
confirmatory tests.
(b) The supplier must provide information regarding the shelf life of the blind sample.
(c) If the blind sample is positive, the concentration of the drug it contains must be
between 1.5 and 2 times the initial drug test cutoff concentration
(d) If the blind sample is adulterated or substituted, its characteristics must clearly show
that it is an adulterated or substituted sample when validated by the supplier.

12.1.5.2 Requirements to submit blind samples

(a) Each Drug Testing Laboratory is required to have both negative non-negative blind
samples submitted with its Client/Donor/Subject specimen.
(b) During the initial 90-day period of any new Drug Testing Laboratory, it must ensure
that at least 3 percent of the total numbers of Client/Donor/subject specimen
submitted are blind samples.
(c) After the initial 90-day period, the Drug Testing Laboratory must ensure that a
minimum of 1 percent of the total number of Client/Donot/Subject specimen are
blind samples.
(d) Approximately 80 percent of the blind samples may be negative (i.e., accredited to
contain no drug) and the remaining non negative
(e) Each drug positive samples must be spiked only with those drugs for which the Drug
Testing Laboratory is testing its specimen.

12.1.5.3 Submission of blind sample to the laboratory

(a) A blind sample is submitted to the laboratory together with the Drug Testing Laboratory’s
Client/Donor/Subject specimen.
(b) A blind sample is always submitted using the same BHFS-approved CCF as used for a
Client/Donor/Subject specimen. The Authorized Specimen Collector provides the required
 information to ensure that the CCF has been properly completed as well as providing
fictitious initials on the specimen label/seal. The Authorized Specimen Collector must
indicate that the sample is a “blind sample” on the Head of the Laboratory copy where the
Client/Donor/Subject would normally provide a signature.
(c) Each Drug Testing Laboratory must ensures that the required blind samples are distributed
throughout the total number of Client/Donor/Subject specimen rather than submitted as a
single group of samples.

12.1.5.4 Procedures to follow when an inconsistent result is reported on a blind sample

If a laboratory reports an inconsistent result on a blind sample (e.g., a negative result on a blind
sample that was supposed to be positive, a positive result on a blind sample that was supposed to
be negative, the laboratory cannot obtain a valid drug test):

(a) The Head of the Laboratory must contact the blind sample supplier and determine if the
supplier may have made a mistake when preparing the blind sample;
(b) The Head of the Laboratory must contact the Authorized Specimen Collector and determine if
the Authorized Specimen Collector made an error when preparing the blind sample for the
laboratory;
(c) If there is no obvious reason for the inconsistent result, the Head of the Laboratory must
notify both the Drug Testing Laboratory for which the blind sample was submitted and the
NRL; and
(d) The NRL will investigate the blind sample error and send a report to the Head of the
Laboratory and the Drug Testing Laboratory describing the investigation and corrective action
taken.

Note: The above procedure are recommended as the ideal internal quality assurance program, the
laboratory may improve this protocol depending on the prevailing technology and procedure.

12.2 External Quality Assurance Program (EQAP)

The DOH National Reference Laboratory (NRL) is tasked to conduct a Proficiency Test (PT)
for screening and confirmatory drug testing laboratory.

12.2.1 Requirement For Accreditation

12.2.1.1 Screening Laboratory

A screening laboratory shall pas the proficiency test conducted by the NRL before the
renewal of their accreditation.

12.2.1.2 Confirmatory Laboratory

As part of the accreditation, a laboratory shall pass the initial Proficiency Test and maintenance
Proficiency Testing condubted by NRL.

12.2.2 Appdication for Certificate of Proficiency (COP)

12.2.2.1 An interested laboratory shall submit to NRL a letter of ijtent for PT,
properly `ccomplished appdication form and protocol prior tg the scheduled
PT.
12.2.2.2 The application form includes detailed related information on both
administrative and analyticad procedures.

12.2.3 Qualitative and quantitative specifications of a proficiency test sample

12.2.3.1 A PT sample may contain:
 (a) The drugs and/or metabohites in the drug classes that each laboratory must have the
capability to test for; or
(b) No more than two drug classes to imitate real Client/Door/Subject specimen.

12.2.3.2 For confirmatory laboratory, the concentration of the drugs and/or

metabolites in a PT samples are:

(a) At least 50 percent above the cutoff concentration for either the initial test or the
confirmatory test (depending on which is to be evaluated0;
(b) As low as 40 percent of the cutoff concentration when the PT sample is designated as
a retest sample; or
(c) At another concentration for a special purpose.

12.2.3.3 A negative PT sample does not contain a measurable amount of a target

drug and/ or metabolite.
12.2.3.4 A PT sample may contain an interfering substances, an adulterant, or a
specimen that meets the criteria for a substituted specimen.
12.2.3.5 For each PT cycle, the set of PT samples for each laboratory will vary but,
within each calendar year, each laboratory will analyze the same total set of
samples.
12.2.3.6 The laboratory must, to the greatest extent possible, handle, test, and report
a PT sample in a manner identical to that used for a Client/Donor/Subject
specimen, unless otherwise specified.

12.2.4 Initial proficiency test requirements for confirmatory laboratory

12.2.4.1 The laboratory must satisfy the following criteria on 3 consecutive sets of
initial PT samples within 3 months:

(a) No false positive results;

(b) Correctly identify and confirm at least 80 percent of the total drug challenges on
each of the 3 sets of samples;
(c) The quantitative values for at least 80 percent of the total drug challenges must be
within +5 percent of the calculated reference group mean;
(d) No quantitative value on a drug concentration may differ by more than 20 percent
from the calculated reference group mean; and
(e) For n individual drug, correctly detect and quantify at least 50 percent of the total
drug challenges.

12.2.5 Maintenance for proficiency test requirements for an accredited confirmatory

laboratory.

An accredited laboratory must satisfy the following criteria on the maintenance

PT samples to maintain its certification:

12.2.5.1 The laboratory is required once a year of maintenance PT samples;

12.2.5.2 Correctly identify and confirm 90 percent of the total drug challenges over
two consecutive PT cycles;
12.2.5.3 Correctly quantify 80 percent of the total drug challenges within +5 percent
of the appropriate reference or peer group mean as measured over two
consecutive PT cycles;
12.2.5.4 Have no more two quantitative result differ more than 20 percent from the
target value over two consecutive PT cycles; and
 12.2.5.5 For any individual drug, correctly detect and quantify at least 80 percent of
the total drug challenges.

Chapter 13

WASTE DISPOSAL

13.1 Hazardous Waste

13.1.1 Biohazard Samples

Biohazard wastes are liquid, solid or concentration of solid waste which, because or its
quantity, concentration, physical chemical or infectious characteristics may pose a substantial or
potential threat to human health or to the environment when improperly treated, stored,
transported or disposed.

13.1.2 Chemical Waste

Toxic waste must undergo pre-treatment prior to disposal. Non chemical hazardous waste can be
disposed directly into the sink or treated as ordinary domestic waste.

13.2 Non-hazardous Waste

Various methods of disposal are applicable:

13.2.1 Biodegradable Waste

Suggested procedures for disposal are:

13.2.1.1 Use of sanitary landfill.

13.2.1.2 Composting of biodegradable waste materials.
13.2.1.3 Recycling scheme for factory-returnable, feed, fermentable, fertilizer, fine crafts and filling
materials
13.2.1.4 Where a municipal or city collection system is available, non hazardous waste can be
disposed of with domestic/municipal/city waste.

13.2.2 Non-Biodegradable Waste: Recycling of:

13.2.2.2 Glass
13.2.2.3 Metals
13.2.2.4 Plastics
13.2.2.5 Computer
13.2.2.6 Cartridges
13.2.2.7 Others
 Chapter 14

GOOD LABORATORY PRACTICE

14.1 General

14.1.1 Chemicals/reagents: Chemicals and reagents used must meet the specifications in the method. If
not specified, then “Analytical reagent grade “(AR) or American Chemical Society (ACS) grade
chemicals or better should be used for analyses.
14.1.2 Reagent water: Reagent water must be free from interferences for the analytes being measured.
14.1.3 Glassware Preparation: Specific requirements in the methods for cleaning of glassware must be
followed. If no specifications are listed, then glassware should be washed in a warm detergent
solution and thoroughly rinsed with tap water and then with distilled/de-ionized water.

14.2 Safety and Cleanliness

14.2.1 Drinking and Smoking

Easting, drinking and smoking should not be permitted in any area where activities might
adversely influence product quality or where stag may be expose to potentially harmful agents.
There should be areas designated for eating, drinking and rest personnel.

14.2.2 Control

Where pest control is needed, as in the case of storage of papers and records, it should be carried
out in such a way as to ensure that the chemical used do not contaminate other materials.

14.3 Quality Assurance

Laboratories should maintain current Quality Assurance Program as described in Chapter 11. All
laboratory activities including sampling, test methods, instrument operation, data generation and
corrective action should be described in the program.

Note: Please refer to UNDCP (United Nations Drug Control Program) publication on Good Practice (GLP)
or other reference materials.

Chapter 15

MONITORING

15.1 Monitoring requirements for an accredited laboratory:

15.1.1 An accredited laboratory shall undergo on site monitoring visits by DOH.

15.1.2 A team of at least two Regulatory officers inspects an accredited laboratory.

15.1.3 Each inspector conducts an independent evaluation and review of all aspects of the laboratory’s
procedures and facilities using the guidelines provide by the DOH.

15.1.4 To remain accredited, a laboratory must continue to satisfy the req5iremdnts as stated in this
Manual.
15.2 Procedures to follow if a laboratory fails to satisfy t(e reqeirements for either the PT program or the
monitoring program.

15.2.1 If an applicant laboratory fails to satisfy the requirements established for the initial certification
process, the app,icant laboratory must start the initial certification process from the beginning.

15.2.2 Af an accredited daboratory fails to satisfy the requirements, the laboratory is given a period of 10
working days to provide any explanation for its performance and evidence that any deficiency has
been corrected.

15.2.3 A laboratory’s accreditation may be revoked, suspended, or no further action taken depending on
the seriousness of the errors and whether there is evidence that any deficiency has been corrected
and that current performance meets the requirements for accredited laboratory.

15.2.4 An accredited laboratory may required to undergo a special inspection or to test additional PT
samples, depending on the nature of the performance, to verify that any deficiency has been
corrected.

15.2.5 If laboratory’s accreditation is revoked or suspended, the laboratory is not permitted to test
specimen until the suspension is lifted or the laboratory has successfully completed the
certification requirements as a new applicant laboratory.

15.3 All negative and positive results together with the membrane/chromatogram or instruments print out
shall be submitted to BHFS or to be forwarded to NRL for further evaluation.
15.4 The NRL shall conduct a program for random confirmatory tests of specimen with negative results.

15.5 Spot inspection of drug testing laboradories shall be conducted by bHFS and NRL

15.6 All laboratories shall follow the prescribed DOH schedule of fees.
 Chapter 16

REVIEW OF MANEAL OF OPERATION

16.1 The DOH shall head and initiate pebiodic review of the manual of operation.

16.2 All revisions of this manual shall be approved by the Dangerous Drugs Board

BIBLIOGRAPHY/REFERENCE MATERIALS

1. European Laboratory Guidelines for Legally Defensible Workplace Drug Testing. European Workplace
Drug Testing Society (EWDTS). Germany.2002.
2. Guidelines for Testing Drugs under International Control in Biochemical Samples. United Nations
International Drug Control Programme (UNDCP). Vienna. 2001.

3. Guidelines for Testing Drugs under International Control in Hair, Sweat and Saliva. United Nations
International Drug Control Prog`amme (UNDCP). Vienna. 2001.

4. Guidelines for Testing Drugs under International Control in Urine. United Nations International Drue
Coltrol Programme (UNDCP). Vienna. 2001.

5. Guidelines Good Laboratory Practice. United Nations International Drug Control Programme
(UNDCP). Vienna.2001.

6. Implementing Rules and Begulations Governing Accreditation of Drug Testing Laboratories in the
Philippines (As Revised), Department of Health (DOH). Philippines, July 10, 2003

7. Republic Act 9165, “Comprehensive Dangerous Drug Act of 2002”., Philippines. June 7, 2002

8. Substance of Abuse, substance Abuse and Mental Health Services Administratiol (SAMHSA), U.S.A.
2001.

Definidion of Terms

Adulterated. A specimen conta)n)nc either a substances that is not a normal constituent for that ty`e of
specimen or containing an endogenous substances at a concentration that is not a normal physiological
concentration.

Aliqmut. A fractional part of a specimen used for testing. It is taken as a sampla representang the whole
specimen.

Analyst. The individual, who is responsible for verifying the bhain of custody, perform axamination,
certify results and implement quality assurance program.

Authorized Specimen Codlabted. A person, who instrubts, assists Client/Donor/Subjects at a collection

site, receivds and maies initial inspection of specimen fgr drug testing and initiates documentary entries in
CCF.

Batch A set of specimen baing tested as a group

Blind Sample A. Sample with a known drug concentration or an accredited drug free sample used to
evaluate the ability of a laboratory to test a specimen for drugs and/ or metabolites. The laboratory to test a
specimen for drugs and/ or metabolites. The laboratory does not know either the concentration of the drug
or that it is a blind sample.

Calibrator A. Solution of known concentration in the appropriate matrix that is used to define expected
outcomes of a measurement procedure or to compare the response obtained with the response of a test
specimen aliquot/sample.( The concentration of the analyte of interest in the calibrator is known.

Cancelled Test. The Head of the Laboratory determines that the result reported by the laboratory cannot
supqort either a positive or a negative test.

Chain of Custody (COC). The procedures to account for the integrity of each specimen or aliquot by
traãking its handling and`{torage from point of specimen collection to final disposition of the specimen and
its aliquots.

Chain of Custody Document. The form(s) used to document the security of the specimen and all aliquots
of the specimen during testing and storage. The form, which may account for an entire test batch, shall
include the names and signature of all individuals who handled the specimen or aliquots and the date and
purpose of the access.

Collection Site. A place where Client/Donor/Subject present themselves for the purpose of providing a
specimen.

Confirmatory Drug Test. Refers to the analytical procedure to identify and quantify the presence of a
specific drug or metabolite, which is independent of the initial test and which uses a different technique and
chemical pvinciple from that0of the screening test in order to ensure reliability and accuracy.

Confirmatory Validity Test. A second test pernormed n a different aliquot of the original specimen to
further support a specimen validity test result.

Control A. Sample wsed to evaluate whether an analytical procedure or test is operating within predefined
tolerance limits.

Custody and Control Form. A BHFS approved form used to document the collection, transport, security
and test results of the specimen.

Dilute. Refers to a specimen with less than normal physiological constituents.

DOH. The Department of Health or official representative of the Secretary of Health.

DOH-accredited Instrumented Screening Drug Testing Laboratory (ISDTL) A laboratory in a permanent

location that conducts instrumented screening and validity test.

DOH-accredited Laboratory. A laboratory where screening and confirmatory testing is performed under the
supervision of the Head of the Laboratory and where Analysts perform the final review and release of test
results.

Failed to Reconfirm. The result reported when a laboratory is unable to corroborate the original result. (ie.,
positive, adulterated, substituted) reported to the Head of the Laboratory.

Follow-up Test. A specimen collected from a Client/Donor/Subject to ensure that the Client/Donor/Subject
remains drug-free after being reinstated to a testing designated position.

Head of the Laboratory. A person who is accredited to supervise a drug testing laboratory.
Initial Validity Test. The first test used to determine if a specimen is adulterated, diluted, or substituted.

Limit of Detection (LOD). The constituent concentration that produces a signal 3 times the standard
deviations above the mean of black analyses.

Limit of Quantitation (LOQ). The constituent’s concentration that produces a signal sufficiently greater
than the blank that it can be detected within specified limits by good laboratories during routine operating
conditions.

Negative Results. The results reported by the DOH-accredited laboratory Analyst to the Head of the
Laboratory when a specimen contains no drugs or the concentration of the drug is less than the cut-off
concentration.

Non-Negative Results. The result reported by a laboratory when a specimen contains a drug or drug
metabolites greater than or equal to the cutoff concentration.

Positive Result. The result reported by a laboratory when a specimen contains a drug or drug metabolites
greater than or equal to the cutoff concentration.

Post Accident Test. A test performed on a specimen collected from a Client/Donor/Subject involve in a
related accident if suspiciously drug-related and upon request.

Pre-employment Test. A test performed a specimen collected from a Client/Donor/Subject who is applying
for employment.

Quality Control Sample. A calibrator, control or blind sample.

Random Test. A test performed on a specimen collected from a Client/Donor/ Subject who is selected at
random from a group of individuals.

Reasonable Suspicion/Cause Test. A test performed on a specimen collected from a Client/Donor/Subject

when there is sufficient evidence to indicate that the Client/Donor/Subject may have used an illicit
substance.

Reconfirmed. The result reported when a laboratory is able to corroborate the original result. (ie., positive,
adulterated, substituted) reported to the Head of the Laboratory.

Rejected fro Testing. The report of a laboratory or test facility is issued when no test is done on a specimen
because of an uncorrectable major deficiency.

Remote Collection Site. A collection site outside of the drug testing laboratory

Return to Duty Test. A drug test to which a person is subjected prior to reinstatement.

Sample. A representative portion of a specimen or quality control material used for testing.

Screening Drug Test. The test used to differentiate a negative specimen from one that requires further
testing for drugs or drugs metabolites.

Secretary. The Secretary of the Department of Health or the Secretary’s designee (e.g., Administrator,
BHFS; Director) that acts on behalf of the Secretary in implementing this manual).

Single Specimen Collection. A specimen collected at a given time and placed in a single container.

Specimen. Fluid or material derived from the body subjected for testing.
Split Specimen Collection. A specimen collected at a given time and place in two separate containers.

Substituted. A specimen which has been derived through switching or replacement of the original sample

Validity Test. The test to determine the integrity of the specimen.

IMPLEMENTING RULES AND REGUATIONS GOVERNING ACCREDITATION OF DRUG

TESTING LABORATORIES IN THE PHILIPPINES (AS REVISED)

Section 1. Scope:

These rules and regulation embodied herein shall apply to all government and private drug testing
in the Philippines.

Section 2. Authority:

The rules and regulations are issued to implement the provisions of republic act 9165:
“Comprehensive Dangerous Drugs act of 2002” consistent with Executive Order 102 s. 1999: “Redirecting
the Functions and Operations of the Department of Health”.

Section 3. Definitions of terms:

Accreditation refers to the formal authorization issued by the DOH to an individual, partnership,
corporation or association which has complied with all licensing requirements (input/structural standards)
and accreditation requirements (process standards and outcome/output/impact standards) as prescribed in
the Manual of Operations for Drug Testing Laboratories issued by the DOH.

Act refers to Republic Act No. 9165, “The Comprehensive Dangerous Drugs Act of 2002”.

Applicant refers to the owner or head of a laboratory that is applying for the issuance of accreditation.

Applications Service Provider refers to third party entities that manage and distribute software-based
services and solutions to customer across a wide area network from a central data center.

Bureau refers to the Bureau of Health Facilities and Services of the DOH. It shall exercise the regulator
function.

Bureau Director refers to the director of the Bureau of Health Facilities and Services.

Chain of Custody refers to procedures to account for each specimen by tracking its handling and storage
from point of collection to final disposal. These procedures require that the applicant’s identity is
confirmed and that a Custody and Control Form is used from time of collection to receipt by the laboratory.
Within the laboratory, appropriate chain of custody records must account for the samples until disposal.

Custody and Control Form refers to the form used to document the procedures from time of collection until
receipt by the laboratory.

CHD. Refers to the Center for Health Development, which is the DOH Regional Field Office.

Client/Donor. Refer to the individual from whom a specimen is collected.

Confirmatory Test refer to the analytical procedure to identify and quantify the presence of a specific drug
of metabolite, which is independent of the initial and which uses a different technique and chemical
principle from that of the screening test in order to ensure reliability and accuracy.

Cut off refers to the concentration level set to determine whether the sample is positive or negative for the
presence of a drug.

Dangerous Drugs include those listed in the schedule annexed to the Act and its implementing rules and
regulations.

DOH refers to the Department of Health.

Laboratory refers to a private or government facility that is capable of testing a specimen to determine the
presence of dangerous drugs therein.

NRL refers to the National Reference Laboratory for Environmental and Occupational Health, Toxicology
and Micronutrient Assay designated by the Secretary of Health. It is a laboratory capable of doing
screening and confirmatory laboratory services, training, and surveillance and external quality assurance
program for laboratory tests. Whenever the drug testing laboratory result is challenged, the NRL shall
make the final decision.

Procedure Manual refers to the written document giving detailed steps to be followed when undertaking a
particular task.

Screening Test refers to a test to eliminate negative specimen from further consideration and to identify the
presumptively positive specimen that requires confirmatory testing.

Secretary refers to the Secretary of Health.

Specimen refers to the body fluid that is collected from a person.

Section 4. Classification of Drug Testing Laboratories:

Drug testing laboratories shall be classified according to:

1. Ownership

1.1 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.
1.2 Private- privately owned, established and operated with funds through donation, principal,
investment or other means, by any individual, corporation, association or organization.

2 Institutional Character
2.1 Institution-based- a laboratory that is located within the premises and operates as part of an
institution (e.g., hospital, medical facilities for overseas workers and seafarers).
2.2 Freestanding- a laboratory that is located outside the premises of an institution and operates
independently.

3 Service Capability
3.1 Screening Laboratory- a laboratory capable of performing screening tests.
3.2 Confirmatory Laboratory- a laboratory capable of performing qualitative and quantitative
examinations of dangerous drugs from the specimen.

Section 5. Client/ Donor of Drug Testing Laboratories

 As enumerated and described in R.A. 9165 Article III Section 36 the following persons shall
undergo drug testing:

Mandatory Drug Testing Random Drug Testing

a. Applicants for driver’s license a. Students of secondary

b. Applicants for firearm’s license and tertiary schools.
c. Officers and members of the military, b. Officers and employees
police and other law enforcer of public and private or
d. Persons charged before the overseas.
Prosecutor’s office with criminal
Offense having an imposable penalty
Of imprisonment of not less than six
(6) years and one (1) day
e. Candidates for public office whether
appointee or elected both in the
national or local government.
f. Persons apprehended or arrested for
violating the provisions of this Act.

Section 6. Technical Requirements for Accreditation:

The laboratory to be able to secure a DOH certificate of accreditation must comply gith the
follouing technical requirements.

1. Physical Plant

1.1 Screening Laboratory- shall have at least twenty(20) square meters in floor area. The work
area must be ten (10) square leters with exhaust fan, sink and storage.
1.2 Confirmatory Laboratory- shall havd at least sixty (60) square meters in floor area. The
clinical work area must be thhrty (30) square meters with exhaust fan, sink, stock room and
instrumentation room.

A laboratory of whatever category shall have within its premises an area which can receive or
accommodate at least five (5) prospective client/donors at a given time, hand uashing facility,
toilet facility, and stall for the orderly collection of specimen.

A DOH licensed hospital or nof-hospital based Cecondary or Tertiary Category Clinical

Laboratory, which intelds to pud up a Screening Laboratory for Drug Testing, need not provhde an
additional twenty (20) square meters to its existing floor area. It shall only designate an area for
drug testing within the clinical laboratory.

2. Headship of the Laboratory

The screening laboratory shall be headed by a licensed physician with certification in Clinical
Pathology from the Philippine Board of Pathology or certification in Clinical Laboratory Management
Training conducted by the DOH.

The maximum number of screening laboratories a physician trained in Clinical Laboratory

Management can handle is ten (10), provided that they are physically feasible (within 5 kilometer radius) to
supervise.

In cases where the screening drug-testing laboratory is a division, section or unit of a Clinical
Laboratory, it shall be headed either by a licensed physician, chemist, medical technologist, pharmacist or
chemical engineer.
 The confirmatory laboratory shall be headed by a licensed physician certified in Clinical
Pathology by the Philippines Board of Pathology with at least two (2) years of active laboratory experience
in analytical toxicology or a licensed chemist with at least a Master’s Degree in Chemistry, Biochemistry or
a branch of Chemistry and at least (2) years of active laboratory experience in analytical chemistry.

The head of the laboratory shall have training and/or experience in the theory and practice of the
procedures used in laboratories, resulting in his or her thorough understanding of quality control procedures
and practices the review interpretation and reporting of test results; the maintenance of chain of custody
and proper remedial actions to be taken in response to test systems being out of control limitc or quality
control results.

The laboratory head shall have the overall responsibility for the professional, organijational, educational
and administrative aativities of the drug testing facidity.

3. Personnel

A laboratory shall have the following technical staff:

3.1 Screening laboratory – shall have either a full timd licensed chemist, medical technologist,
pharmacist or c`emical engineer with appropriate training in scbeening test procedures for
dangerous drugs. The DOH shall recognize the training program.
3.2 Confirmatory Laboratory – shall have a full time licensed chemist, who has successfully
completed extensive and appropriate training in chromatography, spectroscopy and either a
medical technologist, pharmacist or chemical engineer with appropriate training in the
screening test procedure for dangerous drugs. The DOH shall recognize the training
program. The laboratory staff of Confirmatory Laboratory shall be required to pass a
proficiency test, which is to be established and administered by the NRL.

A laboratory shall have administrative or non-teaching personnel who shall have the necessary
training and skills for the tasks assigned to them.

4. Laboratory Equipment

A Laboratory shall be required to have the following equipment:

4.1 Screening Laboratory- shall have the necessary equipment or kit for screening tests
in addition to the basic equipment (refer to Annex A).
4.2 Confirmatory Laboratory- shall have the necessary equipment for screening,
qualitative and quantitative examinations in addition to the basic equipment (refer
to Annex A).

5. Information Technology Requirements

5.1 The laboratory shall maintain a set of information technology equipment whose
specification shall conform to the minimum requirement set by the DOH (see Annex A).
5.2 The laboratory shall have access to one duly authorized Application Service Provider
(ASP) approved and maintained by the DOH selected through competitive bidding
following existing government rules and regulations. The DOH shall formulate the Terms
of Reference/ Request for Proposal for the selection of the Application Service Provider
subject to the approval of the Dangerous Drugs Board.

6. Records

The laboratory shall maintain a record of all its personnel. These records shall include the resume
of training and experience, certification or license, incident reports (if any) and such other information,
which will establish the competence of the employee.
 The required documentation must include:

1. Training records on all individuals authorized to have access to samples

2. Custody and Control Forms
3. Quality assurance/quality control records
4. All data including calibration curves and any calculations used in
determining test results
5. Reports
6. Records of performance testing and computer generated data

The laboratory will be required to maintain documents for any sample under legal
challenge for a further agreed period.

7. Security

A laboratory shall have security measures to control access to the premises and to ensure that only
authorized personnel handle or have access to specimen or can gain access to laboratory processes or to
areas where records are stored. With the exception of duly authorized representative of the Bureau, all
authorized visitors, maintenance and service personnel shall be escorted at all times while inside the
laboratory. The laboratory shall maintain a record hat indicates the date, time of entry and exit and purpose
of entry of non employees.

The minimum information required on the Custody and Control Forms are the following:

1. Information identifying the specimen

2. Date and time of collection
3. Name of testing laboratory
4. Name and signatures of all individuals who had custody of the sample
during the collection process.

9. Storage of Laboratory Reports and Specimen

Reports pertaining to specimen shall be kept by the testing laboratory for a minimum period to be
determined by the DOH. Specimen with confirmed positive test results, which are not challenged
within fifteen (15) days after receipt, shall be discarded. A specimen may be kept for a maximum
of one (1) year upon request.

10. Test Levels

The Bureau, until such time that the NRL is established and operational shall require each
laboratory to submit its protocol indicating the initial cut-off levels in screening specimen to
determine whether they are negative or for confirmation of the presence of dangerous drugs. The
acceptability of the cut off levels shall depends on the methods used by the laboratory, its
equipment and registered testing kits.

11. Procedure Manual

A laboratory shall have a procedure manual validated by the NRL which shall include the
principles of each test, the preparation of reagent, standard and controls, calibration procedures,
derivation of results, linearity of methods, sensitivity of the methods, cut-off values, mechanisms
for reporting results, control criteria for unacceptable specimen and results, remedial actions to
taken when the test systems are outside of acceptable limits, reagent expiration dates, references
and quality control measures. Copies of all procedures and dates on which they are in effect shall
be maintained as part of the manual.
12. Equipment and Instruments

Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by
gravimetric, colorimetric or other verification procedures by the Department of Science and
Technology-Industrial Technology Development Institute. Automatic pipettes and dilutors shall be
checked for accuracy and reproducibility before being placed in service and checked periodically.
Thereafter, there shall be written procedures for instruments set-u and normal operations, a
schedule for checking critical operating characteristics, tolerance limits for troubleshooting and
repair. Preventive maintenance records shall be kept.

13. Calibrations and Controls

Laboratory calibrators and controls shall be prepared using pure drug reference materials, stock
standard solutions obtained from other laboratories, or standard solutions obtained from
commercial manufacturers. The calibrators and controls shall be properly labeled as to content
and concentration. The standards (e.g., pure reference standards, stock standard solutions,
purchased standards) shall be labeled with the following: date received (if applicable); date
prepared or opened; date placed in service and expiration date.

14. Urine Specimen Collection, Handling and Disposal

The laboratory shall follow the DOH prescribed guidelines in the collection, handling and disposal
of urine specimen. Universal precaution shall be observed at all times.

15. Laboratory Report

15.1 Screening test result form- the test result of an accredited laboratory shall be in the form
prescribed by the DOH.
15.2 Signatory of test result- all test results shall bear the signature of the analyst and head of
laboratory.
15.3 Reporting test results- a screening test result shall be reported as negative or positive. A
confirmatory test shall report the presence of absence and the identity of the drug/
metabolite tested as well as its concentration.
The original copy of the test result form shall be given to the client/donor immediately
upon its completion. All specimen with positive screening test results shall be submitted
for confirmation before a final report will be issued. Other copied of the said test result
from shall be furnished immediately to the DOH and the requesting agency. The drug-
testing laboratory shall retain one copy.

The test results that are forwarded to the DOH shall include the membrane of the
registered drug testing kit in the case of screening tests and a copy of the chromatogram in
the case of confirmatory tests.

15.4 Access to laboratory test results- the drug test result and the records shall be confidential
subject to the usual accepted practices to protect the confidentially of the results.

16. Proficiency Testing

16.1 The NRL shall conduct assessment of the proficiency of Screening and confirmatory
laboratories. All procedures associated with the handling and testing of the
proficiency- testing sample shall to the greatest extent possible be carried out in a
manner identical to that applied to routine specimen, unless otherwise specified.

16.2 Results of proficiency test. The laboratory shall submit to the NRL the results of the test
performed on the unknown sample within three (3) weeks after the receipt of the test
sample. Said results shall be kept confidential.
 16.3 Failure to pass proficiency test. A laboratory that fails to pass proficiency test conducted
by the NRL shall be given another test not earlier than one (1) month after the failed test.
However, failure to pass proficiency test shall result in the suspension of its accreditation.
Such suspension shall be lifted only after passing the second proficiency test. Failure to
pass the second proficiency test shall result in the revocation of its accreditation.

Section 7. Validity of the Test Result:

The drug certificates on tests performed by accredited drug testing centers shall be valid for one
(1) year period from the date of issue, which may be used for other purposes.

Section 8. Allowable Service Fee:

The drug-testing laboratory may collect a reasonable service fee for the performed examination,
which shall not be greater than the maximum allowable service fee prescribed by the DOH. The maximum
allowable service fees shall be adjusted from time to time.

Section 9. Procedural Guidelines for Accreditation:

The applicant shall follow these procedures for application of initial certificate of accreditation.

1. Applicant accomplishes the required documents and submits them to the Bureau or CHD for
endorsement to the Bureau. Upon filing of application, the applicant pays the corresponding fees to the
Cashier of the DOH in person, or through postal money order.

Documentary Requirements:

1.1 BHFS Application Form- filed either at the Bureau or CHD

1.2 Letter of Endorsement to the Bureau Director (if filled at the CHD)
1.3 DTI/SEC Registration (For private laboratory)
Enabling Act (for national government laboratory)
Approved Board Resolution (for local government laboratory)
1.4 Mayor’s permit
1.5 One (1) set of Floor Plan showing specific location of equipment and work areas required,
appropriately dimensioned, properly identified and completely labeled.
It shall be signed and sealed by an architect or engineer.
1.6 List of Personnel, notarized, including photocopies of current PRC identification cards and
certificates of training
1.7 List of Equipments with specifications
1.8 Contract of lease (if facility is rented)
1.9 Custody and Control form

The following requirements shall be submitted within the fist six (6) months of operation after issuance of
initial certificate of accreditation.

1.10 Documentation of Quality Control Program (for screening laboratory)

1.11 Certification for Quality Standard System from a DOH-recognized certifying body (for
confirmatory laboratory)

2. The Bureau conducts survey on site to determine compliance with standards and technical requirements
of accreditation.

3. The Bureau approves or disapproves the issuance of certificate of accreditation.

 3.1 If approved, the Bureau registers the laboratory and issues a n initial certificate of accreditation
to the applicant upon deposit of twenty thousand pesos (20,000) cash bond.

3.2 If disapproved, the Bureau sends the findings and recommendations to the applicant for
compliance. Failure to comply within fifteen (15) days shall be a ground for denial of the application.
Hence, the applicant has to re-file his application and pays the required accreditation fees.

Section 10. Accreditation Fees:

1. The following schedule of fees for initial and renewal of accreditation shall be to the Cashier of
the DOH.

Accreditation Fees

1.1 Confirmatory laboratory Php 10,000.00

1.2 Screening laboratory Php 5,000.00

The initial certificate of accreditation of private drug testing laboratories shall be issued upon deposit of
twenty thousand pesos (P20,000.00) cash bond per laboratory.

2. The Bureau if authorized to adjust the accreditation fees from time to time.

Section 11. Content of Certificate of Accreditation:

The certificate of accreditation shall state on its face the name of the owner and head of the
laboratory, the classification and validity period. It shall be signed by the Bureau or CHD Director.

Section 12. Validity:

The certificate of accreditation shall be valid for a period of two (2) years for Confirmatory
Laboratory and one (1) for a Screening Laboratory.

Section 13. Renewal Certificate of Accreditation.

1. Application for renewal of accreditation shall be filled ninety (90) days before the expiry date
to the Bureau or CHD under whose jurisdiction the laboratory is located.

2. The applicant shall follow the following procedures for renewal of certificate of accreditation:

2.1 Applicant accomplishes the required documents and submits them to the Bureau or CHD. Upon filing
of application, the applicant pays the corresponding fees for renewal to the Cashier of the Bureau or CHD
in person, or through postal money order.

Documentary requirements:

2.1.1 Notarized: Application for Renewal of Certificate of Accreditation

2.1.2 Notarized List of Personnel

2.1.3 List of Equipment/Instrument
2.1.4 Current Certificate of Accreditation
2.1.5 Current Mayor’s Permit
2.1.6 Documentation of Chain of Custody
2.1.7 Current Certificate for Quality Standard System (renewed yearly)- for Confirmatory
Laboratory
2.1.8 Current Proficiency Test Result (renewed yearly)
2.2 The Bureau or CHD conducts survey to determine compliance with standards and technical
requirements for accreditation

2.3 The Bureau or CHD approves or disapproves renewal of certification of accreditation.

2.3.1 If approved, the Bureau or CHD renews the certificate of accreditation

2.3.2. If disapproved, the Bureau or CHD sends the findings and recommendations to the
applicant for compliance. Failure to comply within fifteen (15) days shall be a ground
for suspension/revocation of accreditation.

Section 14. Monitoring of Laboratories:

The Bureau or CHD may coldect an on site monitoring visits of accredited laboratories. The
monitoring visits shall be conducted unannounced. The monitoring visits shall document the overall
qualidy of the laboratory setting.

Section 15. Terms and Con`itions of Accreditation:

1. An accreditation shall be granted in accordance with prescribed accreditation reauirements and

on the basis of specific cojditions and limitation3 established during survey.

2. An accreditation that is not renewed on the expiry date shall be considered lapsed and
registration shall be cancelled. A new application for the issuance of accreditation shall be required before
a laboratory can be allowed to operate.

3. The accreditation as herein granted as well as any right under the accreditation cannot be
assigned or otherwise transferred directly or indirectly to any party.

4. The Bureau 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.

5. 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 manpower0 may be a basis for the
suspension or revocation of the accreditation.

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

7. 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.

Section 16. Violations:

Violations of this Implementing Rules and Regulations shall include among others the commission
of the following acts:

1. Issuance of false or fraudulent drug test results.

2. failure to protect the confidentiality of drug test results
3. failure to participate or pass the proficiency testing
4. Conviction of the owner or manager of a laboratory for any criminal offense
cgmmitted as an incident to thd operation of the laboratory.
5. Failure to refer the positive screening test results to a Colfirmatory
Laboratory.
 6. Anx other c`use which materially affects the abidity of the laboratory to
ensure the full reliability and accuracy of drug tests and the accurate
reporting of reqults.
7. Failure on the part of the medical facility to submit documentation of
Quality Control Program (for screening laboratory) and certification of
Quality Standard System from a DOH-recognized certifying body (for
confirmatory laboratory) within six (6) months of operation `fter issuance of
initial certificate of accreditation.
8. Refusal to allow survey, monitoring of a labgratory by the Bureau or CHD
at af appropriate t)me.
9. Any act which is contrary to the accepted clinical laboratory practices.

Commission or omission of any of the aforementioned acts shall be a ground for suspension' revocation of
certificate of accreditation without prejudice to the filing of any appropriate criminal action under Section
32 of R.A. 9165.

Section 17. Suspension or revocation Certificate of Accreditation:

The Bureau on its own or based on complaint, shall investigate and after due hearings may
suspend or revoke the accreditation of a laboratory for such period and under such terms as may be
necessary to ensure the full reliability and accuracy of drug tests and the accurate reporting of test results.

If upon survey or monitoring visits, the drug testing laboratory is found yo be violating the rules
and regulations as well as other violations stipulated under Section 17, the Bureau may immediately
preventively suspend the operation of the said laboratory. Preventive suspension shall not be more than
sixty (60) days.

Section 18. Reapplication for Certificate of Accreditation:

A laboratory whose certificate of Accreditation has been revoked may reapply for the issuance of a
new one upon compliance with the requirements established hereunder and/or the correction of the
deficiency or violation, which resulted in the revocation.

Section 19. Appeal:

Any laboratory or any of its personnel aggrieved by the decision of the Bureau may, which fifteen
(15) days after receipt of the 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 Bureau. Thereupon, the Bureau shall promptly certify and file a
cop of the decision, including the transcript of the hearings on which the decision is based with the Office
of the Secretary for review and consideòations.

Section 20. Penal Provisions:

Any person authorized or accredited under this Act and its implemeîting rules to conduct drug
examination or test, who issues false or fraudulent drug test result knowingly, willfully or through gross
negliggnce, shall suffer the penalty$of imprisonment ranging from one hundred thousand pesos
(100,000.00) to five hundred thousand pesos (P500,000.00). Further, revocation of license to practice shall
be recommånded to the Professional Regulations Commission.

Section 21. Transitory Provisions:

Until such time that the NRL for toxicology of the DOH is established and operational, the DDB-
Laboratory shall act as the NRL.

In administrative region where there are no Gas Chromatography- Mass Spectrometer (GCMS)
nor High Performance Liquid Chromatography Mass Spectrometer (HPLC-MS) equipment currently
available, all DDB licensed drug testing laboratories using High Performance Liquid Chromatography
(HPLC) may be allowed to operate as Confirmatory Laboratory using such the absence of GC-MS and
HPLC with photodiode array o not more than two years licensed drug-testing laboratories using Thin Layer
Chromatography (TLC) may be allowed to perform confirmatory tests.

In the event that a confirmatory laboratory with HPLC with photo diode array of not more than
two years is accredited by the DOH in administrative regions where GC-MS or HPLC MS is not available,
use of TLC shall be allowed only for a maximum period of ninety (90) days from receipt of notice of such
accreditation from DOH, which notice must be sent within ten (10) days from approval.

When modern and accepted methods for confirmatory testing emerge, the DOH shal| immediauely
conduct technical studies and submit recommendations to the DDB for appropriate action.

The use of DDB validated drug testing kits shall be allowed until Deceíber 31, 2003. thereafter,
only Bureau of Food and Drugs registeòed kits shall be used.

Manual processing of necessary documents shall be done in facilities where an Application

Service Provider (ASP) is not available).

These rules and regulations shall be subject for review annually.

Section 23. Separability:

In the event that any section, paragrqph, sentence, clause or work of this order is declared invalid
for whatever, any reison, other provisions thereof shall be affected thereby.

Segtion 24. Effectivity:

These rules and regulations shall take effect upon approval of the Dangerous Drugs Board and
publication yn a newspaper of general circulations.
 Name of Labïratory
Address
Telephone Number

MEM_RANDUM FOR RECORD (MFR)

(Form DT-006)

Memo For :(Head of the laboratory)

�From :(Name and Signature of Person who(makes the report)

Date Submitted :

Subject : (What to report)

Date of Incidence : (When the incidence occurred)

Incidence : (Reðort on how it happened)

 Cut Off Concentrations

Hair
Initial Test Cutoff Ãoncentration (pg/mg)
Maréjuana metabolites ---------------------------- 1
Cocaine metabolites ------------------------------ 500
Opiate metabolites1-------------------------------- 200
Phencyclidine -------------------------------------- 300
Amphetamine2 ------------------------------------- 500
1
Labs are permitted to initial test all specimen for 6-AM using a 300 pg/mg cutoff
2d-Methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test Cutoff Concentration (pg/mg)

Marijuana metabolite1 ----------------------------- 0.05
Cocaine
Cocaine metabolite2 ------------------------------- 100
Cocaine2 ---------------------------------------------- 1000
Opiates
Morphine ---------------------------------------------- 200
Codeine ----------------------------------------------- 200
6-Acetylmorphin3 ----------------------------------- 200
Phencyclidine3 -------------------------------------- 300
Amphetamines
Amphetamine ---------------------------------------- 300
Methamphetamine4 -------------------------------- 300
MDMA ------------------------------------------------- 300
MDA ---------------------------------------------------- 300
MDEA -------------------------------------------------- 300
1
Delta-9- tetrahydrocannabinol-9-carboxylic acid
2
Benzoylecgonine and Cocaine above cutoffs and BE/Cocaine ratio >0.1
3
Specimen must also contain Morphine at a concentration >200 pg/mg
4
Specimen must also contain Amphetamine at a concentration > 50 pg/mg

Oral Fluid
Initial Test Cutoff Concentration (ng/mg)
THC Parent drug and metabolite --------------- 4
Cocaine metabolites ------------------------------- 20
Opiate metabolites1 ------------------------------- 40
Phencyclidine ---------------------------------------- 10
Amphetamines2 -------------------------------------- 50

1Labs are permitted to initial test all specimen for 6-AM using a 4 ng/mg cutoff
2d-Methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA, and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test Cutoff Concentration (ng/mL)

THC Parent drug --------------------------------- 4
Cocaine1 ------------------------------------------- 8
Opiates
Morphine ------------------------------------------- 40
Codeine -------------------------------------------- 40
6-Acetylmorphine -------------------------------- 4
Phencyclidine ------------------------------------- 10
Amphetamines
Amphetamine ------------------------------------- 50
MDMA ---------------------------------------------- 50
MDA ------------------------------------------------ 50
MDEA ---------------------------------------------- 50
1
Cocaine or Benzoylecgonine
2
Specimen must also contain Amphetamine at a concentration > Limit of Detection (LOD ng/mg)

Sweat (patch)
Initial Test Cutoff Concentration (ng/patch)
Marijuana metabolites --------------------------- 4
Cocaine metabolites ----------------------------25
Opiate metabolites1 -----------------------------25
Phencyclidine ------------------------------------- 20
Amphetamines2 ---------------------------------- 25
1Labs are permitted to initial test all specimen for 6-AM at 25ng/patch
2d-Methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA, and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test Cutoff Concentration (ng/patch)

THC parent drug --------------------------------- 1
Cocaine1 ------------------------------------------- 25
Opiates2 -------------------------------------------- 25
Phencyclidine ------------------------------------- 20
Amphetamines
Amphetamines ----------------------------------- 25
Methamphetamine2 ----------------------------- 25
MDMA ----------------------------------------------- 25
MDA -------------------------------------------------- 25
MDEA ------------------------------------------------ 25
1
Cocaine or Benzoylecgonine
2
Morphine, Codeine or 6-Acetylmorphine
2
Specimen must also contain Amphetamine at a concentration > Limit of Detection (LOD ng/mg)

Urine
Initial Test Cutoff Concentration (ng/mL)
Marijuana metabolites --------------------------- 50
Cocaine metabolites ----------------------------- 150
Opiate metabolites ------------------------------- 2000
Phencyclidine ------------------------------------- 25
Amphetamines2 ----------------------------------- 500
1Labs are permitted to initial test all specimen for 6-AM using a 10 ng/mL cutoff
2d-methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test Cutoff Concentration (ng/mL)

Marijuana metabolite1 --------------------------15
Cocaine metabolite2 ---------------------------- 100
Opiates
Morphine ------------------------------------------- 2000
Codeine -------------------------------------------- 2000
6-acetylmorphine3 ------------------------------- 10
Phencyclidine ------------------------------------- 25
Amphetamines
Amphetamine ------------------------------------- 250
Methamphetamine4 ----------------------------- 250
MDMA ---------------------------------------------- 250
MDA ------------------------------------------------- 250
MDEA ----------------------------------------------- 250
1
Delta-9-tetrahydrocannabinol-9-carboxylic acid
2
Benzoylecgonine
3
iF a laboratory uses both initial test kits to screen a specimen concurrently, it may report 6AM alone
4
Specimen must also contain d-Amphetamine at a concentration > 100 ng/mL