Overview:
Drug Testing
Operations for
Laboratories
Allaine Reymar F. David, RMT
Drug Analyst
Republic Act 9165
▪ Also known as the “Comprehensive Dangerous Drug Act of 2002”
▪ Safeguard the state, its citizen from harmful effects of dangerous drugs
particularly the youth
▪ Enhance the efficiency of the law against dangerous drugs
▪ Enhance campaign against trafficking and use of dangerous drugs
▪ Re-integrate drug users back into the society.
Article III, Sec 36: Authorized Drug Testing
▪ Drug testing shall be done by any government forensic laboratory or DOH
accredited and monitored laboratory.
▪ DOH shall set the price/cost of drug testing
▪ Government Forensic Laboratories
-NBI
-PNP
-PDEA
Article III, Sec 36: Authorized Drug Testing
▪ Shall use two methods of testing (Screening & Confirmatory)
▪ Drug Test certificates has a 1 year validity
Original Content of RA 9165
▪ Applicants of Driver’s License
UPDATE
▪ RA 10586 otherwise known as AN ACT PENALIZING PERSONS DRIVING
UNDER THE INFLUENCE OF ALCOHOL, DANGEROUS DRUGS, AND
SIMILAR SUBSTANCES, AND FOR OTHER PURPOSES
▪ “ANTI-DRUNK AND DRUGGED DRIVING ACT OF 2013
RA 10586
▪ SEC 5. Punishable Act – It shall be unlawful for any person to drive a motor
vehicle while under the influence of alcohol, dangerous drugs and/or other similar
substances
▪ SEC 7. Mandatory Alcohol and Chemical Testing of Drivers Involved in Motor
Vehicular Accidents.
- A driver involved in a vehicular accident resulting in the loss of human life or
physical injuries shall be subjected to chemical test, including a drug screening test
and, if necessary, a drug confirmatory test as mandated under RA 9165.
RA 9165
▪ Any person arrested for violations of the provisions of RA 9165, subjected to
screening drug test within 24 hours.
▪ If positive, confirmatory testing within 15 days after receipt of result
(Sec. 38, RA 9165)
R.A 9165 Article III Section 36
▪ As enumerated in this section, the following persons shall undergo drug testing:
Mandatory Drug Testing Random Drug Testing
Applicant for firearm’s license Students of secondary and tertiary schools
Officers & members of the military, police Officers and employees of public and
and other law enforcer private offices whether domestic or
overseas
Person charged before the Prosecutor’s
office with a criminal offense having an
imposable penalty of imprisonment of not
less than six (6) years and one (1) day.
Candidate for public office whether
appointee or elected both in the national or
local government.
Person apprehended or arrested for
violating the provisions of this Act.
Drug Testing Laboratory Overview
The Drug Testing Laboratory performs qualitative
method for the two most common drugs of abuse
using a one step, lateral flow chromatographic
immunoassay designed for the simultaneous
detection of methamphetamine and
tetrahydrocannabinol metabolites in human urine.
This test is intended for professional in vitro
diagnostic use only.
Classification of Drug Testing Laboratories
▪ Ownership ▪ Service Capability
-Government -Screening – performs screening tests
-Private
-Confirmatory – performs qualitative
and quantitative examinations
▪ Institutional Character of dangerous drugs from
specimen
-Institution-based
-Freestanding
Laboratory Personnel
▪ DTL Owner
▪ Head of the Laboratory (Clinical Pathologist, Licensed Physician with certification in
Clinical Lab Management)
▪ Technical Personnel
-Analyst (Chemist, RMT, Pharmacist, Chemical Engineer)
-Authorized Specimen Collector
-Laboratory Aide/Encoder
▪ Administrative Personnel
-Clerk
-Secretary
The two most commonly used drugs of abuse testing are
Methamphetamine (Shabu) and Tetrahydrocannabinol
(Marijuana).
Substance/s tested:
▪ Methamphetamine is an ▪ Tetrahydrocannabinol is the active
amine derivative of chemical in cannabis and is one of
the oldest hallucinogenic drugs
amphetamine, in the form of known. It comes from the flowering
its crystalline hydrochloride as tops and leaves of the hemp plant,
a central nervous system cannabis sativa, more commonly
stimulant, both medically and known as the marijuana drug.
illicitly.
Work Flow:
Receipt of requests - is the time when the request is received in the laboratory by the analyst
usually around 10 minutes.
Specimen collection - is the collection of urine specimen in the comfort room around 5 minutes.
Drug testing proper - is the time when the client is fingerprinted, encoded, have his picture taken
and the urine is tested with the dual test kits around 15 minutes.
Official result and issuance-the releasing of drug test result usually after 1 hour or depending on
the number of clients present around 2 hours at the least.
Validation
DTLs should register online in the IDTOMIS website for scheduling of validation of new kits. The
schedule of validation in the DOH-CHD is every Tuesday and Thursday only.
CHD technical support shall approve the schedule.
DTLs analyst should go to the CHD on the approved schedule with the new DTKs (Drug Test
Kits) for validation in IDTOMIS.
CHD Technical Support should validate the DTKs and approve in the IDTOMIS website. The
validated DTKs can now be used for drug testing.
IMS should print daily the approved DTKs per region and load approved DTKS in IDTOMIS to
the DTOMIS system.
DTLs should use IDTOMIS primarily and should only use DTOMIS in case there is problem.
DTLs should submit used DTKs to the CHDs.
After the transition phase, the CHDs should reconcile actual DTK balance in DTLs to ensure the
accuracy of the IDTOMIS DTK inventory.
In case that the IDTOMIS has problems, the CHD should accommodate inspection of DTKs
brought by the DTLs for validation. The approved validated number should be manually
recorded and immediately encoded to the IDTOMIS once the system is available.
Definition of Terms
DTL- refers to Drug Testing Laboratory
CHD - refers to the Center for Health Development, which is
the DOH Field Office.
DTK - refers to the Drug Test Kit use
IDTOMIS-refers to the Integrated Drug Testing Operations
Management Information System.
IMS – refers to the Integrated Management Service
Specimen Collection - Urine Specimen
Standards
A significant policy for the collection of urine specimens for drug testing involves the
presence of the analyst who should assist the client. The authorized specimen
collector should be the one to safeguard the specimen and see to it that no
substance is added to the urine.
The client should wash and dry hands prior to handling the collection device. After
washing hands, the client 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.
The ASC should verify the donor’s identification, explain the basic collection
procedure, and answer any reasonable and appropriate questions regarding the
collection procedure.
Specimen Submission- Urine Specimen
Standards
After the specimen is collected, the authorized specimen collector should inspect the specimen
for signs of tampering and fills up steps 2 of the CCF.
A tampered specimen should be sent to the laboratory for testing and the authorized specimen
collector should document the tampering on the CCF.
When a tampered specimen is collected, the authorized specimen collector should immediately
collect another specimen. The second specimen must also be sent to the laboratory.
Once collected, the authorized specimen collector and client must keep the specimen in view at
all times prior to sealing the specimen container.
The client signs step 5 of the CCF.
The collector should bring the specimen to the laboratory. The ASC and the analyst should then
sign the CCF.
The urine should be tested with the one-step immunoassay drug screening test.
Specimen Rejection- Urine Specimen Standards
Criteria for Rejection of Urine Specimen (Observed)
All rejected specimen should be reported to the head of the laboratory stating
the reason for rejection.
Non Correctable:
Incompatible ID number on the specimen received by the lab with the number
on the CCF.
No ID number on the specimen.
No printed authorized specimen collector’s name and signature on the CCF.
Broken or tampered seal on the specimen container.
If the volume of the urine specimen is less than 60mL.
Correctable
Failure of the authorized specimen collector to sign the CCF.
Failure to check and record the specimen temperature with appropriate
remarks.
Specimen Rejection- Urine Specimen Standards
Criteria for Rejection of Urine Specimen (Unobserved)
1. Adulterated Specimen
The nitrite concentration is confirmed to be greater than or equal to
500ug/L.
The pH is less than 3 or greater than or equal to 11.
The specimen contains an exogenous substance.
The specimen contains an endogenous substance at a concentration
greater than what is considered a normal physiologic concentration.
2. Substituted Specimen
When both the initial and confirmatory creatinine tests and confirmatory
specific gravity tests have the following results
The specific gravity is less than 1.002 or greater than 1.020.
Specimen Rejection- Urine Specimen Standards
Diluted Specimen
When the initial or confirmatory tests have creatinine and specific
gravity results of:
creatinine concentration is less than 1768.0 umol/L.
specific gravity is less than 1.003.
creatinine and specific gravity results do not meet the criteria
for a substituted or invalid result
Invalid Specimen
Adulterated substituted and diluted.
Improperly collected, handled and stored.
Improperly documented.
Handling of Positive Specimens and Results for
Confirmatory Testing
•Urine specimens for drug test that yields a positive for Methamphetamine
(MET) and /or Tetrahydrocannabinol (THC) by the Screening Drug Testing
Laboratory (SDTL) are required by law to undergo confirmatory testing in
an accredited Confirmatory Laboratory as stated in the Implementing
Rules and Regulation governing accreditation of Drug Testing Laboratories
in the Philippines.
•The specimen should be brought to an accredited confirmatory laboratory
within 15 days to avoid delays in the result. The laboratory should be
required to maintain documents for any sample under legal challenge for a
further agreed period.
Official Results
The analyst should encode the client’s data and other information based on the consent
form he has written before and perform fingerprinting.
The analyst should perform drug testing on the client’s urine using the authorized drug
testing kits duly approved by the DOH-CHD.
The analyst should encode the result through the computer which will give an official
result.
The analyst should instruct the client to sit beside before the analyst who will encode his
information and proceed to fingerprinting and picture taking.
Inform the client on the result of the examination.
Results are ready after two hours or depending upon the number of urine submitted.
Notes to Remember
All urine specimens whether it yield a positive or a negative result are
placed inside the refrigerator.
Negative urine specimens usually last in the refrigerator for 5 days. After
that it will be discarded in the sink.
Positive urine specimens are stored in the refrigerator within 15 days if the
client decides to confirm the result to a confirmatory laboratory.
Otherwise, it will stay in the screening laboratory ref for up to one year.
Only the head of the laboratory will decide if the positive urine specimen
will be discarded after one year.
END
Q&A Reference: National Reference
Laboratory Manual (MANOPS)
Existing SDTL SOP – PUDCI