SOP DRUG TESTING
SOP DRUG TESTING
PROCEDURE
DRUG TESTING LABORATORY
(SCREENING)
VISION
In the next ten years we aim to be a model drug testing center in
detecting promptly the illegal use of Dangerous Drugs to maintain a
drug-free community.
MISSION
To achieve and maintain a high standard of work by dedicating
ourselves to client/patient service and satisfaction. To be a preferred
partner and a one-stop testing service provider as we use science and
technology to give people the answers they need to improve their lives
or the lives of others and T\o test for multiple drugs to ensure that
clients' testing programs operate at the highest standard
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.
ORGANIZATIONAL CHART
DTL OWNER
HEAD OF LABORATORY
TECHNICAL PERSONNEL:
ADMINISTRATIVE PERSONNEL:
ANALYST
CLERK
AUTHORIZED SPECIMEN COLLECTOR
SECRETARY
LABORATORY AIDE
QUALIFICATIONS OF PERSONNEL
1. Head of the Laboratory
In a Screening Laboratory must be
o A licensed physician certified in Clinical Pathology by the Philippine Board of
Pathology; or
o A licensed physician trained in laboratory management and drug testing operation
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:
Theory and practice of the drug testing procedures used in the laboratory;
Chain of custody, reporting, and record keeping;
Review and interpretation of test results;
Quality assurance program; and
Dangerous drugs regulations and policies
The Head of the Laboratory has the following functions and responsibilities:
Administrative
o Has general and overall supervision of the facility and all aspects of laboratory
work;
o Has general supervision and conduct of all laboratory personnel;
o Formulates and implements standard operation manual that govern the operation
of the DTL. This shall be periodically reviewed and updated;
o Prepares financial and annual reports of the laboratory;
o Provides other administrative support services such as communications, security
and maintenance services.
Technical
o Supervises and directs all analytical procedures of the laboratory;
o Assures quality of all laboratory test results;
o Issues, signs out and interprets laboratory results;
o Evaluates and recommends reagents, supplies and equipment;
o Reviews the CCF and reports received from authorized collector;
o Interviews the Client/Donor/Subject, if necessary;
o Reviews pertinent medical records of Client/Donor/Subject, if necessary;
o Cancels the results of all specimen which are not collected or tested not in
accordance with the DTL manual;
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
o Reviews, rejects, and refers for confirmation and retesting all specimen and test
results that are positive, adulterated, substituted or invalid;
o Implements remedial actions necessary to maintain satisfactory operation and
performance in the laboratory
o Directs protocol for preventive maintenance of equipment;
o Provides comprehensive, continuing training and education of personnel related to
conduct of DTL.
2. ANALYST
The personnel must be a registered:
o Chemist
o Chemical Engineer
o Medical Technologist
o Pharmacist
The analyst must have training in the following:
o Analytical methods and procedures;
o Maintenance of chain of custody;
o Reviewing and reporting test results;
o Proper remedial action in response to problems that may arise;
o Quality control procedures and practices
o Dangerous drugs regulations and policies.
4. ADMINISTRATIVE PERSONNEL
LABORATORY RECEPTIONIST
o Entertain inquiries about Drug testing and receive incoming call
o Check referrals
o Interview client for personal data
o Identify purpose of the test
o Checks and confirms client’s true identification
o Instruct client to fill-up DT forms (DCF and CCF )
o Charge client for the test
o Endorse client to ASC for orientation of the collection process
o Maintain well organized result
o Release result to client or authorized individual; instruct client to receive the result by
signing the receiving/releasing logbook.
LABORATORY AIDE
o Support services
o In charge on housekeeping
o Helps in preventive maintenance program
o Facilitate proper waste management program
o Function on Remote collection
Receive and transport specimen from remote collection
Maintain security of DT forms and specimen during transport
Maintain proper storage and handling of sample during transport
Endorse specimen and all accompanying DT documents/materials properly to
accessioned
WORK SCHEDULE
SEE SEPARATE SHEET ATTACHED
STAFF MEETINGS
The laboratory shall conduct regular meetings to address the needs of the
section, service improvements, system, activities and organization. Meeting is
done quarterly.
CLIENT’S FEEDBACK
A feedback form shall be made available to clients. The documents shall be filed and
regularly reviewed to assess laboratory performance and client service
o COLLECTION SITE
Collection site shall be a designated area within the laboratory or a temporary facility
located at a remote site.
A collection site must have the following
A suitable clean surface for handling the specimen and completing the required
paperwork.
A secured temporary storage capability to maintain a specimen un l it is tested
or shipped to the laboratory.
An era to provide Client/Donor/Subject privacy appropriate to the specimen being
collected.
A controlled and secured area for supplies and records
A poster of information bulletin with a detailed description of the proper
specimen collection process.
f. A source of water for hand washing external to toilet facility (for urine
collection)
Collection of specimen at a temporary/remote facility can only be conducted at the
following locations/conditions
Workplace/school/jail or prison/rehabilitation center for random testing, follow-
up, reasonable suspicion/cause and crime scene and post-accident.
Person who are critically ill/disabled.
Collection of specimen for all mandatory drug testing (e.g. driver’s license, R.A.9165)
shall be dibe at a permanent facility except for crime scene and post-accident.
o SPECIMEN
TGH drug testing laboratory only collects urine as specimen. It is usually used for pre-
employment, random, reasonable suspicion/cause and mandatory drug testing. The minimum
quantity of urine to be collected is 60ml in a single container or 30ml each in 2 separate
containers for split specimen.
***the 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. For transportation of
specimen, it 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.
1. Minimize the number of personnel handling the specimen
2. Document that date and the purpose on the CCF each time a specimen mishandled and
transferred. Identify each person who handled the specimen. When courier services are
utilized, the time of receipt from the collection site and time of delivery to
the laboratory must be documented on the CCF.
3. Place specimen in sealed transparent plastic bag and an appropriate transport container
designed to minimized damage, and seal them securely to eliminate the possibility of
tampering.
4. Ensure that the CCF accompanies the appropriate specimen transport container.
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
issue a receipt-of-delivery slip. The receiving laboratory must record and report any
apparent tampering with the container or specimen, any discrepancy in the specimen and
the CCF.
3. SPECIMEN REJECTION/CANCELLATION
All rejected specimen should be reported to the Head of the Laboratory (HOL) stating the
reason(s) of rejection.
CRITERIA FOR SPECIMEN REJECTION THAT ARE NON-
CORRECTABLE
o Incompatibility of the ID number on the specimen received by the laboratory
with the number on the CCF
o Absence of ID number on the specimen
o No printed Authorized Specimen Collector’s name and signature on the CCF.
o Broken or tampered seal on the specimen container.
o .Insufficient quantity of specimen
CRITERIA FOR SPECIMEN REJECTION THAT IS CORRECTABLE
o Failure of the Authorized Specimen Collector to sign the CCF.
o Failure to check and record the specimen temperature with appropriate
remarks.
APPROPRIATE REMEDIAL MEASURES FOR CORRECTABLE ERRORS.
o All errors must be properly documented, recorded in a Memorandum for
Record (MFR) and duly signed by the Authorized Specimen Collector.
o If the Authorized Specimen Collector’s signature cannot be corrected by a
MFR, the laboratory must report the specimen rejected for testing and provide
a reason on the report
o If the Authorized Specimen Collector cannot provide an MFR to attest to the
fact that he/she did measure the specimen temperature, the laboratory may
CHAIN OF CUSTODY
o DRUG TESTING CUSTODY AND CONTROL FORMS (CCF)
Bureau of Health Facilities Services (BHFS) approved Drug Testing Custody and Control
Form (CCF) must be used to document the collection of specimen. The form is used to document
chain of custody from the time a Client/Donor gives specimen to the Authorized Specimen
Collector until the specimen is received for testing.
o ACCESSIONING
Laboratory provide a unique number upon entry of the specimen to the testing facility. It
must also inspect the specimen submitted and the CCF to verify the integrity and identity of the
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
specimen. Compare the information on the sample bottles within the package with the
information on the accompanying CCF and examine the packaging for evidence of tampering in
transit. The DTL document all discrepancies.
o SECURITY MESURES
The laboratory control access of unauthorized individual and ensure that no unauthorized
individual can gain access to specimen, aliquots, or records. All authorized visitors must be
escorted at all times and they must log their information in the logbook provided for visitors
inside the laboratory which indicates the date, time of entry and exit
3. FOR pH:
a. Dipstick, ph. paper or spectrometric/colorimetric tests may be used for
initial validity test.
b. A pH meter shall be used to perform confirmatory validity test.
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
c. The initial and confirmatory pH meter test shall have the following
controls:
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.
For the cutoff of greater than or equal to 11, one control in the range of10
to 10.9 and one control in the range of 11.1 to 12.
Spectrometer/colorimetric initial pH test shall have the following:
a. For the cutoff of less than 3, one control in the range of 2 to 2.9
b. For the cutoff of greater than or equal to 11, one control in the range
of11.1 to 12
The client shall fill-in and sign the Consent and Chain of Custody Form. (Valid ID
STANDARD OPERATING PROCEDURE
should be presented) **If the client is taking drugs for medication, he must inform2023
the
2 personnel handling the drug test.
DRUG TESTING (SCREENING)
CORPUZ CLINIC AND HOSPITAL
The client shall log the Date of Collection, his Full name and Signature to two
8. THE SCREENING TEST SHALL BE CONDUCTED WITHI THE DAY
POSITIVE NEGATIVE
If the urine specimen tested positive, the same shall be challenged within
fifteen (15) days after the client's receipt of the result.
V1.0 NONE
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