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SOP DRUG TESTING

The document outlines the Standard Operating Procedure (SOP) for drug testing at Corpuz Clinic and Hospital, detailing the vision, mission, objectives, and organizational structure of the drug testing laboratory. It specifies the qualifications, duties, and responsibilities of personnel involved in drug testing, as well as policies for hiring, training, and handling complaints. Additionally, it includes protocols for specimen collection, equipment maintenance, and quality assurance to ensure compliance with regulations and maintain high standards of service.

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0% found this document useful (0 votes)
811 views35 pages

SOP DRUG TESTING

The document outlines the Standard Operating Procedure (SOP) for drug testing at Corpuz Clinic and Hospital, detailing the vision, mission, objectives, and organizational structure of the drug testing laboratory. It specifies the qualifications, duties, and responsibilities of personnel involved in drug testing, as well as policies for hiring, training, and handling complaints. Additionally, it includes protocols for specimen collection, equipment maintenance, and quality assurance to ensure compliance with regulations and maintain high standards of service.

Uploaded by

CCH Laboratory
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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STANDARD OPERATING

PROCEDURE
DRUG TESTING LABORATORY
(SCREENING)

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
ADMINISTRATIVE POLICIES AND
PROCEDURES

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
I. VISION, MISSION, AND OBECTIVES

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.

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
II. POLICY FOR HIRING, ORIENTATION AND PROMOTION FOR
ALL LEVELS OF PERSONNEL

 Please refer to Standard Operating Procedure page 6 to page 13.

III. DUTIES AND RESPONSIBILITIES OF PERSONNEL

 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

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
 In a Confirmatory Laboratory must be
o 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
o 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:
 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.

The functions and responsibilities of the analyst are as follows:


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

3. AUTHORIZED SPECIMEN COLLECTOR


There shall be a designated authorized personnel within the laboratory to collect the
specimen who must
o Be at least a high school graduate
o Have undergone appropriate training
An Authorized Specimen Collector must have undergone training in:
o Collection procedure for each type of specimen;
o Chain of custody and record keeping
o Specimen integrity and security; and
o Dangerous drugs regulations and policies.
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
Retraining of Authorized Specimen Collector shall be required under the following
conditions:
o The collection procedure changes significantly (e.g., a new CCF is used); or
o 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:
o Restricts unauthorized personnel to enter the collection sited during collection;
o Verifies identity of the Client/Donor/Subject;
o Provides security to specimen supplies, records and documents at collection site;
o Informs the Client/Donor/Subject the procedures of specimen collection;
o Performs only one specimen collection at a time;
o Accepts and seals the specimen container in the presence of the Client/Donor/Subject;
o Accomplishes CCF.
The following are persons who are not authorized to collect specimen:
o Employer of the Client/Donor/Subject
o Investigator at the crime scene
o Complainant
o Owner/Administrator of establishment

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.

 THE FOLLOWING PERSONS ARE NOT AUTHORIZED TO COLLECT SPECIMEN.


1. Employer of the Client/Donor/Subject.
2. Investigator at the crime scene.
3. Complainant.
4. Owner/Administrator of the establishment

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
 LABORATORY ENCODER
o Must have knowledge on the operation of IDTOMIS
o Input charge slip and original receipt number to server
o Checks client for a pending case thru IDTOMIS
o Enter all results and DTL records in the duly Authorized Service Provider
o Upload new submitted transaction and receive pending case
o Encoder prints and prepares the result for signature
o Record all DT record to respective logbook
o All handled DT documents; accomplished DT forms must be properly filed, secured
and well-organized

 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.

IV. CONTINUING PROGRAM FOR STAFF DEVELOPMENT AND


TRAINING AND QUALITY PLAN
PROGRAM PLAN OF MANAGEMENT TO ASSURE COMPETENCE AND INTEGRITY
OF THEDRUG TESTING PROCESS
EVALUATION AND PERSONNEL DEVELOPMENT
 The laboratory must establish criteria for evaluation of performance of all
personnel.
 Training records must be maintained for all personnel. These should include
all job related formal trainings taken by the personnel which pertains to any

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
aspect of their responsibilities, including but not limited to analytical
methodology, laboratory safety, sampling, quality assurance and data analysis.
 The Head of the Laboratory must evaluate the performance of all personnel as
the need arises.

OBJECTIVE: Continual improvement of the organization’s overall performance


o Regular meetings to discuss and critique and performance of the laboratory in
general and each staff in particular, the needs for changes and improvements, and
to present any updates or changes in procedures.
o Regular, preferably yearly, training of personnel to update procedural techniques,
skills and knowledge.
o Regular, yearly and also randomly as needed, proficiency tests to evaluate
personnel competencies.
o Regular, monthly and also randomly as needed, inspection of facilities to assure
adherence to standards.
o Annual review and re-evaluation of procedures and performance.
o 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.
o The Head of the Laboratory must evaluate the performance of all personnel as the
need arises.

V. POLICY FOR DISCIPLINE, SUSPENSION, DEMOTION AND


TERMINATION OF ALL PERSONNEL AT ALL LEVELS
 See Standard Operating Procedure Manual pages 14-15.

VI. PROTOCOL FOR HANDLING COMPLAINTS AND


LABORATORY ACCIDENTS
1. The complainant shall be invited inside the laboratory to discuss the problem. The
concerns shall be discussed in a convenient area where the complainant can freely state
the encountered problems.
2. Only the concerned client shall be entertained first to discuss the matter, the officer in-
charge listens to complaints and identifies the cause of the problem; involved/attending
lab staff, other company/companion of the complainant necessary for the clarification of
the issues shall also be called in appropriate time.
3. Appropriate action or remedies or corrective measures shall be given immediately to
address the complaints of client and to satisfy his/her needs on the service.
4. Explain laboratory policies if complains resulted from the Standard Operating Procedure.
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
5. Appropriate measures, medical treatment, first aid shall be delivered/executed in all cases
of laboratory accident and all other service obligations and necessary settlement.
6. All complaints and other related activities shall be documented. The case shall be studied
and identify solutions/ remedies in order to prevent the recurrence of the problem

 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

VII. POLICY FOR WASTE MANAGEMENT AND HOUSEKEEPING


 See Standard Operating Procedures Manual on pages 25-30.

VIII. POLICY FOR EQUIPMENT MAINTENANCE AND REPAIR


1. COLLECTION DEVICE
For urine specimen: screw capped, wide mouth, 30 or 60mL capacity
polyethylene specimen container.
*** The collection device should not affect or alter the specimens collected.
2. CALIBRATION AND MAINTENANCE
o All equipment must be calibrated and maintained according to the procedures in
the manufacturers’ manual.
o There is a record indicating that the equipment has been calibrated and/or checked
on a regular schedule based on established procedures
o .Trained personnel should be assigned to calibrate equipment regularly.
o Corrective actions and recommendations must likewise be documented when
instruments fail to function as expected
o Contents of calibration/maintenance record.
 Name of instrument, model, serial number
 Name of accessory parts
 Name and address of local distributor
 Date and amount of purchase
 Date of calibration
 Date of malfunction
 Date of repair/corrective action(s) taken
 Recommendations; and
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
 Name of authorized person who performed the calibration/maintenance of
equipment.

3. LIGHTING AND VENTILATION


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

TECHNICAL POLICIES AND


PROCEDURES

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
1. SPECIMEN COLLECTION/ SAMPLING (WITHIN THE
LABORATORY) & REAGENTS, STANDARDS AND CONTROLS

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.

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
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.
No examinations must be conducted at a temporary collection facility.

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.

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
2. RECEIVING, ACCESSIONING AND RELEASING OF SPECIMEN
1. OBSERVED SPECIMEN COLLECTION FOR URINE
Observed samples are to be collected in the presence of the Authorized Specimen Collector
(ASC).The Authorized Specimen Collector shall:
a. Prepare and secure all collection supplies, materials and record.
b. Verify the Client/Donor/Subject’s identification.
c. Explain the basic collection procedure to the Client/Donor/Subject.
d. .Answer any reasonable and appropriate questions the Client/Donor/Subject
may ask regarding the collection procedure.

1. BASIC STEPS IN COLLECTING URINE SPECIMEN FOR DRUG TESTING


o The client/donor removes all unnecessary outer garments (such as jacket,cap) after
which, he/she will be subjected to a bodily search.
o The Authorized Specimen Collector (ASC) directs the client/donor to empty his/her
pockets and check items that may be used to adulterate the specimen.
o The client/donor washes and dries hands prior to collection. After washing hands,
the client/donor must remain in the presence of the ASC and must not have access to
anything that could be used to affect the integrity of the specimen.
o The ASC allows the client/donor to select the collection bottle from available
supplies. The specimen bottle is opened in full view of the client/donor. The ASC
directs the client/donor to go to the toilet facility for urination and to provide at least
60ml of urine sample.
o The ASC shall observe closely the entire collection procedure and take note of the
conduct and demeanor of the client/donor for attempts of substitution, adulteration
and dilution of specimen.
o A tampered specimen is sent to the laboratory for validity testing and the ASC shall
document the tampering on the CCF with appropriate remarks. The ASC shall
instruct the client/donor to provide another urine sample immediately under direct
observed collection. The second specimen shall also be sent for examination.
o After the client/donor hands the specimen, the ASC must measure the temperature,
check volume and inspect its characteristics.
o The ASC and client/donor must keep the specimen in full view at all-time prior to
sealing of all specimen containers.
o A tamper-evident label must be used to secure the entire specimen container.
o Both ASC and client/donor must affix their signature on the seal together with the
date and time of collection.
o The ASC must complete steps 1 and 2 and initiates step 4 of CCF.
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
o The client/donor must affix his/her signature at step 5 of the CCF. The ASC may ask
the client/donor to list any prescription, medication he/she may have taken for the
past two weeks.
o 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.
3. UNOBSERVED SPECIMEN COLLECTION
Unobserved samples are collected in the absence of Authorized Specimen Collector o submitted
samples that are not collected from the collection site or laboratory. Unobserved samples are
subject to specimen validity test.
CONDITIONS WHEN UNOBSERVED SPECIMEN COLLECTION IS ALLOWED:
o When the Client/Donor is physically unable to go to the laboratory or
designated collection site.
o Involved in a crime scene
o Involved in post-accident
o Critically ill

2. 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:
a. To deter the solution of the 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
b. The ASC will ask the client/donor to remove any unnecessary outer garments such as
jacket or cap that might conceal items that could be used to tamper with or adulterate the
client/donor urine specimen. He/She shall be objected to bodily search. The ASC will
ensure that all personal belongings such as purse or briefcase remain with the outer
garments.
c. The client/donor will be instructed to wash hands and dry it prior to urination. After
washing hands, the client/donor will remain in the presence of the ASC 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.
d. The ASC will ask the client/donor to get a clean specimen container from the available
supplies. The client/donor may provide his/her specimen in the privacy of a toilet cubicle
or otherwise partitioned area that allows for individual privacy. The client/donor will be
instructed not to flush the toilet until the specimen is handed to the ASC.
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
e. After the client/donor hands the specimen, the ASC must measure the temperature, check
volume and characteristics. Inspect the specimen to determine its color and appearance of
any signs of contaminants. Any unusual findings will be noted on the CCF.
f. Both the client/donor and the ASC will keep the specimen bottles in view at all times
prior to the urine specimen being sealed and labeled
1. The specimen bottle have an identification label that contains permanent information
such as date and time of specimen collection, signatures of the client/donor and ASC and
specimen ID number.
2. The Authorized Specimen Collector will fill-up steps 1 and 2and initiates step 4 of the
CCF and pack together with the urine specimen immediately for dispatch to the analytical
laboratory.

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

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
report the test result for the specimen but indicate that the Authorized
Specimen Collector could not provide an MFR to recover the omission.
 CONDITIONS THAT WILL NOT CAUSE SPECIMEN REJECTION OR
CANCELLATION
At the receiving area:
o Discrepancies of the laboratory name and address
o Incomplete/incorrect/unreadable employer name or address
o Name of Head of the Laboratory is not indicated
o Incomplete/incorrect address of the Head of the Laboratory
o Incorrect entry or the client/donor ID number
o Unmarked “reason for test” box
o Unmarked “drug test to be performed” box
o The collection site address is not indicated
o Unmarked “specimen collection” box
o The date and me of collection is not indicated
o Unmarked “observed” box (if applicable)
o Incorrect entry of name of delivery/courier service
o The Client/Donor/Subject’s name inadvertently appears on the laboratory
copy of the CCF or on the tamper-evident labels use to seal the specimen
bottles
Within the laboratory:
o Failure to print and sign the accession’s name
o Failure to print and sign the Analyst’s name
o The Analyst accidentally initials the CCF rather than providing signature
for a non-negative result (Analyst’s initials are acceptable for a negative
result.
o The accessioned fails to mark one of the “primary specimen bottle seal
intact” boxes, but the laboratory reported a “rejected for testing” result
with an appropriate comment on the “remark” line.
*** 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 Authorized Specimen Collector
of laboratory personnel (whoever is responsible for the error) to immediately take corrective
measures to prevent the recurrence of the error.
 SITUATIONS/ERRORS THAT MAY REQUIRE THE HEAD OF THE
LABORATORYTO CANCEL A TEST

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
o The client/donor’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’s refused to sign the form.
o The Analyst failed to sign the CCF for a specimen being reported drug positive,
adulterated, substituted, rejected for testing or invalid test result.
o 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 results.
 CORRECTIVE MEASURES THAT THE HEAD OF THE
LABORATORY MUST DOPRIOR TO CANCELLATION
o The Head of the Laboratory must contact the Authorized Specimen Collector to
obtain a statement to verify that the client/donor refused to sign the laboratory
copy. If the ASC cannot provide such statement, the Head of the Laboratory must
cancel the test.
o The Head of the Laboratory must obtain a statement from the Analyst that he/she
inadvertently forgot to sign the CCF, but did, in fact, properly conduct the
certification review.
o The Head of the Laboratory must require the laboratory to modify and retransmit
a corrected electronic report.

 CONDITIONS FOR RETENTION OF SPECIMEN


o A specimen reported negative for a minimum of 5 days after the receipt of result.
o A specimen reported either as positive, adulterated, substituted or invalid result
for a minimum of 15 days upon receipt of the result. A specimen maybe retained
for a maximum of 1 year upon request. If no such request is received, a specimen
may be discarded.
o A retained specimen must be kept in a secured location appropriately to ensure its
availability for any necessary retesting during an administrative or judicial
proceeding.

 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

 URINE SPECIMEN VALIDITY TEST


A validity test is a test to determine the integrity of the specimen Validity procedures for
unobserved urine collection to determine the integrity of the specimen
PERFORM INITIAL VALIDITY TESTS
Urine physical conditions in the following conditions:
 Temperature
 Abnormal physical appearance (e.g. color, odor, excessive foaming)
 Reactions or responses characteristic of an adulterant obtained during initial or
confirmatory drug tests. (e.g. non-recovery of standards, unusual response)
 Possible unidentified interfering substance or adulterant. The choice of additional
validity tests is dependent on the observed indicators or characteristics.
Urine specific gravity, pH and nitrites
Urine creatinine concentration
Validity test/s for presence of oxidizing adulterants as needed.
 PERFORM CONFIRMATORY VALIDITY TESTS USING ALL OTEHR
PROCEDURES, INSTRUMENTSAND/OR METHODS ON THE SAME
SAMPLE.
**All unobserved samples for validity testing shall be submitted to an accredited drug testing
facility with at least a secondary clinical laboratory capability.
*** Validity test for other types of specimen shall be incorporated for future reference.
CRITERIA FOR DETERMINING URINE SPECIMEN
1. INVALID
a. Adulterated, substituted and diluted
b. Improperly collected, handled and stored
c. .Improperly documented
2. ADULTERATED

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
a. The nitrite concentration is confirmed to be greater than or equal to500ug/L
b. The pH is less than 3 or greater than or equal to 11
c. The specimen contains an exogenous substance4.The specimen contains an
endogenous substance at a concentration greater than what is considered a normal
physiological concentration.
3. SUBSTITUTED
a. The creatinine concentration is less than 442.0 umol/L
b. Specific gravity is less than 1.002 or greater than or equal to 1.020
4. DILUTED
a. The creatinine concentration is less than 1768.0 umol/L
b. The specific gravity is less than 1.003
 PROCEDURES FOR CONDUCTING EACH VALIDITY TEST ON A URINE
SPECIMEN
1. 1.FOR CREATININE CONCENTRATION
a. The creatinine concentration shall be measured to one decimal place on
both the initial test and confirmatory test.
b. The initial creatinine test shall have a calibrator at either 442umol/L or
at1768umol/L
c. The initial creatinine test shall have a control in the range of 176.8umol/L
to 353.6umol/L, a control in the range of 442 umol/L to 1768 umol/L, and
a control range of 1856.4umol/L to 2210 umol/L
d. The confirmatory creatinine test ( performed on that specimen with a
creatinine concentration less than 442umol/L on the initial test) shall have
a calibrator at 442 umol/L or at 1768umol/L, a control in the range
of176.8umol/L to 353.6umol/L, and a control in the range of 530.4umol/L
to707.2umol/L

2. FOR SPECIFIC GRAVITY


a. The specific gravity shall be measured using s refractometer on both initial
and confirmatory test. The refractometer shall be capable of reading in
increments of at least 0.001 or less.
b. The initial and confirmatory specific gravity test shall have the following
controls:
 For the cutoff of less than 1.002, one control at 1.001 and one control in the range of 1.015 to
1.020.
 For the cutoff of greater than or equal to 1.020, one control greater than or equal to 1.02 but
not greater than 1.025, and one control in the range of 1.015to 1.020.3.

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

4. FOR OXIDIZING ADULTERANT TESTS


a. At a minimum, the initial test(s) for oxidizing adulterants shall be capable
of detecting nitrites, chromates and halogens (bleach, iodine etc.,). The
detection of these adulterants may be achieved by using either a general
oxidizing adulterant test or by using specific test for o 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
200mg/ml of nitrite as an LOD. Each analytical run of specimen shall
include a control without the compound of interest and at least one
positive control with one compounds of interest at a concentration, which
exhibits an oxidizing activity above the documented LOD of the
procedure.
b. A confirmatory test for a specific oxidizing adulterant shall use a different
analytical principle one chemical reaction than that used for the initial test
unless a recognized reference method is used for both initial and
confirmatory test. Each analytical run of specimen shall include a control
without the compound of interest and a positive control with the
compound of interest at a concentration above the documented LOD in the
procedure.
5. FOR NITRITE CONCENTRATION
a. Dipsticks may only be used to determine if initial and confirmatory nitrite
test shall be performed.
b. A nitrite specific initial test shall have a calibrator at the cutoff
concentration, a negative control, one control in the range of 200mcg/l
to500mcg/ml and one control at the range of 500mcg/l to 625mcg/l.

The collection of urine samples shall be conducted by a DOH-accredited Drug


Testing Laboratory personnel
1

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

The urine sample shall be separated


from the nefative specimens for The urine sample
confirmatory test. is discarded.

A confirmatory test shall be


immediately comducted.

The client shall be informed of the results of the


screening and the confirmatory drug tests within
five (5) days from the respective dates they were
conducted, said results shall be signed by the Drug
Testing Laboratory

If the urine specimen tested positive, the same shall be challenged within
fifteen (15) days after the client's receipt of the result.

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
FLOWCHART FOR SPECIMEN TESTED POSITIVE IN DRUG
TEST SCREENING LABORATORY

4. REFERRAL TO CONFIRMATORY LABORATORY WHEN POSITIVE


RESULTS WAS OBTAINED
1. Requirements
 Urine sample
1. Volume must be 60 mL.
2. Samples submitted after 30 days from date of collection will be
REJECTED.
3. Specimen must be properly labeled, properly packed and must be
cold/frozen upon arrival.
 Documents
1. Requests for confirmatory must be IDTOMIS generated with
ORIGINAL signature of the Head of the Laboratory and the
Laboratory Analyst.
2. Custody and Control form (CCF-002D) with ORIGINAL signature of
the Head of the Laboratory, Laboratory Analyst, and ASC. Specimen
CODE must be the same code found in the sample.
5. REMOTE COLLECTION
As per:
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
[ BHFS BUREAU CIRCULAR NO. 07 S. 2003, October 02, 2003 ]
GUIDELINES FOR REMOTE COLLECTION OF DRUG TESTING SPECIMEN
1. Only drug testing laboratories accredited by the Department of Health shall be allowed to
perform collection of drug testing specimen at a temporary/remote facility.
2. No collection of drug testing specimen at a temporary/remote facility shall be done without
PERMIT FOR REMOTE COLLECTION OF DRUG TESTING SPECIMEN (PRC-DTS)
secured only from the DOH-BHFS/CHD not later than ten (10) working days prior to the
scheduled collection.
3. The following are the documentary requirements:
3.1 Letter of request to conduct remote collection
3.2 Notarized MOA/contract between the contracting parties
3.3 List of authorized personnel employed at the laboratory designated for remote
collection
3.4 Operational procedures for remote collection and transport (collection, transport,
handling).
3.5 List of supplies, transport materials eg. Ice chest
4. A fee of Php 2,500 shall be collected from the laboratory for each site.
5. The PRC-DTS shall be valid only on the date specified on the permit.
6. The collection site should be located within the same administrative region as the applicant
laboratory and accessible only by land travel with no more than 2 hours of land travel.
7. The permit shall be posted in a conspicuous area within the laboratory and temporary facility
located at a remote site.
8. The DOH-BHFS shall have the prerogative to inspect the proposed facility prior to the
issuance of the permit. A collection site shall have a secure and suitable area for specimen
collection/storage, supplies and records.
9. The said facility shall be subject to monitoring during the time of collection.
10. No drug testing examination shall be conducted at a temporary collection facility.
11. The minimum number of clients/donor for a remote collection site shall not be less than 50.
12. A copy of the accomplished record of remote collection shall be submitted (see Annex A * of
assessment tool).
13. In case of failure to perform the collection at a specified date, the laboratory shall inform the
DOH-BHFS/CHD in writing within a day before the scheduled date for re-scheduling. The
schedule will be set at the discretion of the DOH-BHFS/CHD.
14. Violations of the terms and conditions stated herein and in the IRR governing accreditation
of DTLs and Manual of Operations (MANOPS) shall be the basis for suspension/revocation of
the PRC-DTS and the accreditation of the laboratory.
Adopted: 2 Oct. 2003

6. ANALYTICAL PROCEDURE AND MECHANISM OF REPORTING


RESULTS
The laboratory shall maintain specimen test results supported by data and are reported in
accordance with the following written guidelines.
o GUIDELINES FOR REPORTING LABORATORY RESULT

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
a. All specimen submitted shall have a corresponding laboratory result
issued within 15 days.
b. A positive screening result shall be subjected to confirmatory analysis.
The final report shall be based on the confirmatory result.
c. The screening laboratory shall be the only authorize laboratory to release
the final report.
d. All laboratory reports of a screening laboratory shall bear the signature of
the Analyst and the Head of the Laboratory. For a confirmatory
laboratory, the report shall bear the signature of the Analyst, Chief
Chemist and Head of the Laboratory.
e. All confirmatory drug test result 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.
f. A laboratory shall report all test results using DOH-accredited standard
electronic laboratory report form, the electronic report must be transmitted
in a manner that ensures the confidentiality and security of the
information.
g. Reports for an adulterated or substituted test result must be based on an
initial and confirmatory validity test.
h. The laboratory must report the specific validity test result(S) for a
specimen that is reported adulterated or substituted.
i. No result can be relayed through telephone.
o STATISTICAL SUMMARY OF THE LABORATORY REPORT
a. A laboratory must submit annually to the BHFS a report containing the following:
a. Total number fo specimen received and examined as classified according
to:
i. Mandatory
ii. Random
iii. Other reasons
b. Number of specimen that were reported as:
i. Positive for each drug
ii. Adulterated
iii. Substituted
iv. Rejected for testing
v. Invalid result
b. The number of specimen sent for confirmatory testing (for screening laboratory)
a. The report must be submitted to the BHFS by mail, fax, or email within
10 working days..
o REVIEWING A POSITIVE, ADULTERATED, SUBSTITUTED, OR INVALID
TEST RESULT

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
a. 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:
a. Allow the Client/Donor/Subject to explain any circumstance leading to
the test result.
b. Evaluate alternative medical explanations for the positive, adulterated,
substituted, or invalid test results.
c. Review current medical record of the Client/Donor/Subject that could
have resulted from taking legally prescribed medication.
o WHEN THE LABORATORY REPORTS AN INVALID RESULT DUE TO
THE POSSIBLE PRESENCE OF AN UNIDENTIFIED INTERFERING
SUBSTANCE/ADULTERANT, THE HEAD OF THE LABORATORY SHALL:
a. Send the specimen to another DOH accredited laboratory capable of
identifying the interfering substance/adulterant.
b. Report the result as “Test Cancelled” if the explanation provided by the
Client/Donor/Subject is:
 Acceptable, then an immediate direct observed collection is not
required.
 Not acceptable, then an immediate direct observed collection is
required.
o FOR VERIFICATION, THE CLIENT/DONOR/SUBJECT MAY OBTAIN
OTHER DOCUMENTS.
a. The Client/Donor/Subjects must submit a written request addressed to the
head of the Drug Testing Laboratory to obtain a certified true copy of COC
and pertinent analytical data.

7. PROCEDURE FOR SECURITY AND CONFIDENTIALITY OF


RECORDS, SUPPLIES AND SPECIMEN
o Chain of custody
i. The chain of custody (COC) records must reflect the actual chain
of custody procedures(e.g. the movement between individuals or
movement to/from temporary storage) that are used for handling
specimen
o Memorandum for Records
i. It is a record to document specimen that had been rejected or
cancelled. It includes reason and corrective measures done.
o Result of Analysis
i. Records for all screening/confirmatory test results and/or of the document
contain the following:
1. Test result
2. Test result of control/calibrator/standard
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
3. Laboratory identification of specimen tested.
4. Identification of individual performing and reviewing the test result.
5. Evidence of review by the certifying Analyst in confirmatory tests.
6. Evidence of confirmatory work sheets or other review documents of
comparison of the initial and confirmatory testing data to ensure
consistent results.
7. Strikeout changes made on test results and other records must be
properly annotated by the responsible individual.
o Inventory of reagent, supplies and materials
i. There must be a record of all reagents, supplies and materials used.
o Equipment, maintenance and repair record
i. The equipment, maintenance and repair record should document that all
instruments are properly maintained, calibrated, cleaned and monitored
including corrective measures and recommendations done.
o Storage of collection site records
i. Collection site records must be stored for a minimum of 2 years in the
laboratory or as required by law.
o Quality Assurance Program Record
i. Internal quality control
ii. External quality control
o Storage of laboratory results
i. A laboratory must retain all records generated to support test results for at
least 2 years.
ii. However, all other records associated with positive result or a particular
specimen under legal challenge shall be maintained for an indefinite period.
o Electronic storage system
i. A DOH-accredited laboratory shall store and archive all records electronically
to duly authorized application service provider.
ii. The laboratory must validate that the method used to create the electronic
records provides an accurate representation of all original records
iii. The method used to create the electronic records must prevent the alteration of
any stored information.
iv. The method used must allow easy retrieval and reproduction of the original
records.
v. The laboratory shall ensure the integrity of data electronically stored under its
information technology facilities without prejudice to pertinent statuses on
privacy/confidentiality and transparency.
vi. The laboratory shall ensure the integrity of data by transmitting it
electronically from their facility to DOH within the prescribed time and
measures to counter disruption of transmittal are installed.

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
vii. 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 loss of records.
viii. Electronic transmittal if drug testing results shall be coursed by the DOH
authorized application service provider.

8. STORAGE AND DISPOSAL OF SPECIMEN * FOR CDTL, INCLUDE


STORAGE AND DISPOSAL OF CHEMICALS
o HAZARDOUS WASTE
i. BIOHAZARD SAMPLES
 Biohazard wastes are liquid, solid or concentration of solid waste which,
because of its quantity, concentration, physical, chemical or infectious
characteristics may pose a substantial or potential threat to any human health
to the environment when improperly treated, stored, transported or disposed.
ii. 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.
o NON-HAZARDOUS WASTE
i. VARIOUS METHODS OF DISPOSAL ARE APPLICABLE.
a. Biodegradable waste
i. Use of sanitary landfill
ii. Composting
iii. Recycling scheme
iv. As domestic/municipal waste
b. Non-biodegradable waste: recycling of:
i. Glass
ii. Metals
iii. Plastics
iv. Computer
v. cartridges

9. INTERNAL QUALITY ASSURANCE PROGRAM


Internal Quality Assurance Program (IQAP)
1. Screening laboratory
2. Validation of a screening drug test
 The laboratory must demonstrate and document:
o The ability to differentiate positive and negative samples
o The performance of the test around the cutoff concentration
o The performance of the test results at several concentrations between 0 to
150 percent of the cutoff concentration
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
 Perform characteristics of new lots of testing kits must be evaluated prior to its
use.
 Batch quality control requirements when conducting a screening drug testing for
kits only
o Each batch of specimen must contain the following types of QC samples:
1. At least one controlled registered and validated by the DOH to contain
no drug metabolite
2. At least one control that has the concentration of the drug or
metabolite at 25 percent above the cutoff concentration
3. At least one control that has the concentration of the drug or
metabolite at 25 percent below the cutoff concentrations.
 Analytical and quality control requirements for performing urine specimen
validity tests
i. 1.A validity test result for a specimen shall be based on performing an initial
(first) validity test on one aliquot and a confirmatory (second) validity test on a
second aliquot. in some cases, both validity tests may use the same procedure,
instruments, and/ or method.
ii. 2.The performance characteristics (e.g., accuracy, precision, LOD, LOQ,
linearity, specificity) shall be documented for each “validity test as appropriate
iii. 3.The LOD of suspected adulterants shall be determined
iv. 4.Each analytical run of specimen “for which an initial or confirmatory validity
test is being performed shall include the appropriate calibrators and controls.
 Blind Samples Submitted by a Drug Testing Laboratory
i. A blind sample must be validated as to its content by the suppler using initial and
confirmatory tests.
ii. 2.The supplier must provide information regarding the shelf life of the blind
sample.
iii. 3.If the blind sample is positive, the concentration of the drug it contains must be
between 1.5and 2 times the initial drug test cutoff concentration
iv. 4.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.
 Requirements to submit blind samples
1. Each Drug Testing Laboratory is required to have both negative non-negative
blind samples submitted with its Client/Donor/Subject specimen.
2. 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.
3. After the initial 90-day period, the Drug Testing Laboratory must ensure that a
minimum of 1 percent of the total number of Client/Donor/Subject specimen are
blind samples.
4. Approximately 80 percent of the blind samples may be negative (i.e., accredited
to contain no drug) and the remaining non negative
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
5. Each drug positive samples must be spiked only with those drugs for which the
Drug Testing Laboratory is testing its specimen.
 Submission of blind sample to the laboratory
1. A blind sample is submitted to the laboratory together with the Drug Testing
Laboratory’s Client/Donor/Subject specimen.
2. 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 infectious 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.
3. 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.
 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):
1. 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;
2. 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;
3. 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
4. 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.

10.EXTERNAL QUALITY ASSURANCE PROGRAM


1. The DOH National Reference Laboratory (NRL) is tasked to conduct
a Proficiency Test (PT) for screening drug testing laboratory.
2. A screening laboratory shall pass the proficiency test conducted by
the NRL before the renewal of their accreditation.
 Application for Certificate of Proficiency (COP) An interested
laboratory shall submit to NRL a letter of intent for PT, properly
accomplished application form and protocol prior to the scheduled

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
PT. The application form includes detailed related information on
both administrative and analytical procedures.
 Qualitative specifications of a proficiency test sample
o A PT sample may contain the drugs and/or metabolites in the
drug classes that each laboratory must have the capability to
test for; or No more than two drug classes to imitate real
Client/Door/Subject specimen.
o An accredited laboratory must satisfy the following criteria on
the maintenance PT samples to maintain its certification
1. The laboratory is required once a year of maintenance PT
samples;
2. Correctly identify and confirm 90 percent of the total drug
challenges over two consecutive PT cycles;
3. Correctly quantify 80 percent of the total drug challenges
within +5percent of the appropriate reference or peer group
mean as measured over two consecutive PT cycles;4.Have no
more two quantitative result differ more than 20 percent from
the target value over two consecutive PT cycles; and5.For any
individual drug, correctly detect and quantify at least 80
percent of the total drug challenges

11.GOOD LABORATORY PRACTICE


o GENERAL
o A chemical 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 for chemicals or better should be used for
analysis.
1. Reagent water must be free from interferences for the analytes being measured.
2. 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 and then distilled/de-ionized water.

o SAFETY AND CLEANLINESS


STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
 Drinking and Smoking
o Eating, drinking and smoking should not be permitted in any area where
activities might adversely influence product quality or where staff may be
exposed to potentially harmful agents. There should be areas designated
for eating, drinking and rest personnel.
 Control
o 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.
o QUALITY ASSURANCE
 Laboratory must maintain current QAP. All laboratory activities including sampling,
instrument operation, data generation and corrective action should be described in
that program.

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
TOPIC AND PURPOSE: REVIEW PERIOD:

DRUG TEST LABORATORY (SCREENING) GUIDELINES,


PROCEDURE AND PROTOCOLS 2 YEARS
VERSION NUMBER: ANNEX:

V1.0 NONE
WRITTEN BY:

YSABELLE ANNE Q. TUGADE, RMT (ANALYST)


REVIEWED BY:

HANNA LEE YAGO, RMT (CHIEF MEDICAL TECHNOLOGIST)


AUTHORIZED BY:

MODESTY A. LEAÑO, MD (HEAD OF LABORATORY)

STANDARD OPERATING PROCEDURE


DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL
STANDARD OPERATING PROCEDURE
DRUG TESTING (SCREENING) 2023
CORPUZ CLINIC AND HOSPITAL

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