ABBREVIATIONS

BHFS –Bureau of Health Facilities Services

CCF – Custody and Control Form

DOH – Department of Health

DTL – Drug Testing Laboratory

NRL – National Reference Laboratory

PT – Proficiency Testing

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Administrative Policies and

Procedures

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 MISSION
To provide confidential and cost effective drug testing.

VISION
To play a part in the suppression of drug dependence among citizenry.

OBJECTIVES
1. To deliver reliable results to uphold the trust and confidence of
clients.
2. To perform our duty to enhance the healthcare system in the
pursuit of a drug-free community.
3. To provide drug testing to aid the potential health, safety, and
performances of members of the community workplace.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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 ORGANIZATIONAL CHART

Dr. Ponciano S.
Limcangco
Head of Laboratory

Malyka C. Capital,
RMT
DRUG ANALYST

Jappy B. Quintas
Authorized SPecimen
Collector

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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DTL Personnel
The Drugtesting Laboratory Staff is composed by:
1. Clinical Pathologist
2. Drug Analyst
3. Authorized Specimen Collector
 Functions of the DTL Personnel
1. Clinical Pathologist
 Supervises the overall of DTL.
 Supervision of conduct of personnel.
 Formulation and implementation of Standard Operational
Procedures.
 Refers positive for confirmatory testing.
 Interviews Client/Donor/Subject for alternative medical
explanations.
 Review the CCF Form and other documents.
2. Drug Analyst
 Verifies completeness of CCF.
 Prepares specimen for analysis.
 Examines, records, releases and signs out reports.
 Assists in evaluation of reagents, supplies/equipment.
 Assists in QA
 Performs specimen validation tests.
 Institutes corrective measures to prevent cancellation of test.
 Documents and reports all laboratory activities.
3. Authorized Specimen Collector
 Handles, transports and stores specimen correctly.
 Recommends rejection of test as the need arises.
 Accomplishes Memorandum for Record.
 Ensures specimen integrity at collection and security of
procedure.
 Accomplishes CCF correctly.
 Performs initial specimen validity.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Policy for Hiring, Orientation and Promotion for all Levels of Personnel
HIRING AN EMPLOYEE

1. A complete resume and job description is required and preferred

experience is included.
2. Interviews are being set up in a suitable place for the interviewee.
3. An applicant must present his/her credentials.
4. Final decision on the hired applicant are decided after a thorough
checking of the documents submitted and related references.
5. Salary is offered formally before hiring.

POLICY ON PROMOTION
1. The personnel hired will undergo one month training inside the laboratory.
2. Probationary status for 6 months to 1 year shall follow after successfully
passing the one month training. Regularization is given at the end of the
probationary period depending on the performance of the personnel.
WORKPLACE COMMITMENTS
1. Employees are prohibited from consuming controlled substances such as
alcohol and prohibited drugs while at work inside the laboratory
premises or outside while engaged in the laboratory business.
2. Any violation thereof will be subject to disciplinary action and
termination.
COMPENSATION AND EMPLOYEE BENEFITS
1. Pay day falls on the 15th and the 30th of every month. This gives in detail
the number of days worked, overtime and deductions, and computed
compensation per hour.
2. Employees are to notify the management for inaccuracy that may have
been committed on their pay slip.
3. Hourly rates are given to employees for overtime rendered in service to
the laboratory.
4. The employees contribution to the PAG-IBIG, SSS, PHILHEALTH are
shouldered by the management of PCC Health Diagnostics Center.
5. On retirement, an employee shall received the SSS insurance.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Continuing Education/Training Program
1. All Personnel are to attend Government/Private workshops, training, and
seminars to develop knowledge, skills and ability as part of their
capability building enhancement.
2. Every personnel should be computer literate.
3. Feedback from clients are recognized as a tool for staff improvement.

Policy for Discipline, Suspension, Demotion, and Termination at All Levels

of Personnel
Voluntary Termination:
The company requests that the employee provide two (2) months
advance written notice. This request does not alter employees at will
relationship with the company. All rights and privileges of employment
with the company terminate upon the date of separation. Terminating
employees are required to return all company property assigned to them.
Failure to do so may result in the withholding of their final pay check.
Actions that are unacceptable and considered grounds for disciplinary action
and suspension but are not limited to:
1. Being under the influence of controlled substance alcohol in the
laboratory premises or outside engaged in laboratory tasks.
2. Unauthorized use of company property, equipment, devices, assets.
3. Damage, destruction or theft of company property, equipment,
devices, assets.
4. Removing company property without prior authorization or
disseminating company information without authorization.
5. Falsification, misrepresentation or omission of information without
authorization, lying.
6. Insubordination or refusal to comply with directions.
7. Failing to adequately perform job responsibilities.
8. Excessive or unexcused absenteeism or tardiness, illegal or violent
activities.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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 9. Disclosing confidential or proprietary information without permission.
10.Falsifying injury reports or reason for leave.
11.Disregard for safety and security procedures.
12.Disrespect of superiors and co-workers.
13.Any other actions or conduct that is inconsistent with company
policies, procedure, standards and expectations.
Upon termination, an employee is required to:
1. To continue to work until the last scheduled day of
employment.
2. To turn in all reports and paper works required to be completed
by the employer when done and no later than the last day of
work.
3. To return all files, documents, equipment, keys, software or
other properties belonging to the company that are in the
employee’s possession custody or control and to turn in all
possessions to the management.
4. To participate in an exit interview.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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 HANDLING COMPLAINTS

 A record logbook is available for recording and analysis complaints.

 Any outward incident shall immediately be reported to the superior staff.
 A written incident report with the time, date, incident and circumstances,
personnel concerned is to be specifically stated. Remedy and corrective
measures is also stated in the finished report. (Complaints and Client
Feedbacks Logbook)
 Discussions and consultations with the superior staff and the Pathologist.

QUALITY PLAN
 PCC Health Diagnostics Center shall ensure customer satisfaction by:
 Maintaining and controlling documented procedures of its quality
system and confidentiality of records.
 Non-conformance and the corrective actions are done promptly and
continuous quality improvement and programs are done regularly.
 Reviews and approves purchasing documents for adequacy of the
specified requirements prior to release.
 Verification of purchased products – Where the documentation proposed
to verify purchased services at the subcontractor’s premises, management
shall specify verification arrangement, and the method/service release in
the purchasing documents.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Policy for Waste Management and Housekeeping

 Toxic waste must undergo pre-treatment prior to disposal.

 Non-chemical hazardous waste can be discarded/disposed directly into
the sink or treated as ordinary domestic waste.
 Urine Disposal – Specimen which yielded negative drug test report
are discarded by splashing in the toilet bowl. Disinfection of bowl
is done consequently.
 Biodegradable Waste: Collected by city/municipal collection system
disposal.
Vermin Control
1. Water containers should be covered.
2. Waste bins are emptied everyday.
3. Comfort rooms are cleaned and maintained to avoid inappropriate odor.
4. The whole premises is sprayed with insecticide at least once a week.

Policy for Equipment Maintenance and Repair

 A record must be kept with the date of purchase, date of cleaning, date of
maintenance, date of replenishment and Technician’s signature with the
date of malfunction.
 All malfunctions must be reported immediately.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Technical Policies and

Procedures

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 A. Equipment, Supplies, and Fixtures

 Refrigerator – Properly maintained and functional, strictly for urine

specimen.
 Laboratory thermometer inside, daily temperature monitoring is
recorded and posted on the unit.
 Information Technology Equipment
 Windows XP operating system
 Fingerprint Biometric Scanning Device
 Webcam
 Ink/Laser Printer
 DOH-IDTOMIS
 Specimen Container
 60 ml polyethylene, wide mouth with screw cap.
 Plastic Bag
 Transparent, self-sealing/sealable and leak proof, capable of
containing the specimen and pertinent documents (CCF).
 Gloves – disposable
 Cabinet – With lock to secure and store records and supplies.
 Tables/Chairs/Bench –allotted for personnel, benches can
accommodate at least 5 clients at the same time.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Specimen Collection/Sampling
 Specimen Collection in the Laboratory is an OBSERVED
COLLECTION.
 Observed samples are collected in the presence of the ASC.
 The Client/Donor/Subject is asked to fill-up the CCF before specimen
collection.
1. The Client/Donor/Subject removes all unnecessary outer garments (coats,
jacket), after which he/she will be subjected to bodily search.
2. The ASC gives the collection container and is directs the Client/Donor to
the toilet for urination.
3. The Client/
Donor/Subject provides at least 60 ml urine collected either single or
split, then hands specimen to the ASC.
4. The ASC seals and labels the specimen.
5. The specimen collector affixes signature on the seal together with the
date and time of collection.
6. The Client/Donor affixes signature on the seal of the specimen container.
Receiving, Accessioning and Releasing of Specimen
Upon receiving the specimen from the Client/Donor/Subject:
1. The CCF must accompany the specimen.
2. Check the volume of the urine in the specimen container.
3. Inspect the specimen to determine its color and appearance for any signs
of contaminants.
Any unusual findings will be noted on the CCF.
4. The ASC hands the specimen to the Drug analyst for further accession
and testing.
5. A unique accession number is provided upon entry of the specimen to the
laboratory.
6. The specimen submitted and the CCF are inspected to verify the integrity
and identity of specimen.
7. After analysis of the specimen by the analyst, the client/donor
information and result is encoded in the computer.
8. The accessioner then releases the result to the client and both fills up the
releasing logbook.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Specimen Rejection/Cancellation
Forms of Tampering Specimen:
 Dilution
 Substitution (bringing of voided urine)
 Adulteration *addition of substances like:
a. Bleach
b. Ammonia
c. Liquid Soap
d. Table Salt
e. Vinegar
f. Juice and etc.
 Any suspected adulteration *like too much bubbles, discoloration and
odor change of the specimen is subjected to rejection.
Non-correctible
1. Incompatibility with ID # on the specimen and the CCF.
2. Absence of ID labels in specimen.
3. No name and signature of ASC.
4. Broken and tampered seal.
5. Insufficient quantity of specimen.
All rejected/cancelled specimen should be reported to the Head of the
Laboratory stating reason/s of rejection.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Referral to Confirmatory Laboratory when Positive Results were Obtained
 Positive screened results are sent to Southern Philippines Medical
Center (SPMC) Confirmatory Drug Testing Laboratory.
 Properly labeled urine specimen in sealed container is placed in a
sealed plastic bag, this is transported with the CCF.
 An official receipt used for transport of specimen to confirmatory
laboratory DTL is kept for record purposes.
Policy on Remote Collection
Specimen are collected at a temporary facility located at a remote site.
Allowable Conditions:
 Workplace, School, Jail, Prison, or Rehab Centers
 Follow-up Collection
 Critically disabled
 Random Test Collection.
A permit is secured from BFHS 10 working days prior to scheduled collection.
Drug testing of the samples should be performed in the laboratory and not at the
remote collection type.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Reagents, Standards and Controls
Screening Phase: Performs a validated test to differentiate negative specimen
from a specimen that requires further testing for drugs and/or metabolite.
 A registered testing kits approved by the FDA-DOH using immunoassay
technique.
 Drugtest Kits are an easy, fast, qualitative, visually read competitive
binding immunoassay method for screening without the need of
instrumentation.
 The method employs unique mixture of monoclonal and polyclonal
antibodies to selectively identify the drugs of abuse and their metabolites
in test samples with a high degree of sensitivity.
 Stability: Temperature and Humidity, Shelf life (expiration date)
An Internal and External Quality Assurance Program is practiced.
 Upon validation of test kits, the following are recorded in a logbook:
 Date and time validated
 Parameters
 Method
 Kit Lot no.
 Expiration date
 Control samples and results with corresponding remarks,
recommendation and signature of analyst.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Analytical Procedure
 Uses instrumented screening method.
Urine Specimen Validity Test
 Temperature: Should be between 32-38 degree Celsius
 Abnormal Physical Appearance- (color, odor, excessive foaming)
 Volume of specimen must be at least 60mL

Pipette and Read (Indicator Mark)

Cross Reactivity (interferences)

1. Drug and drug metabolites with significant structural similarities to the
target analyte may cross-react with target analyte specific antibodies,
producing false-positive results.
2. Degree to which any substrate other than the target substrate interacts
with an antibody.
Cut-off Values/Concentration
1. Presumptive Positive- samples with concentration at or above cut-off level.
2. Presumptive Negative- samples with concentration below cut-off value.
Marijuana – Window of Detection: 2 days to 3 weeks
Initial Screen: 50 ng/dL
Metamphetamine – Window of Detection: 2-3 days
Initial Screen: 1000 ng/dL

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Mechanism of Reporting Results
Guidelines for reporting a laboratory result:
 All specimen submitted shall have a corresponding laboratory result
issued within 15 days.
 A positive screening result shall be subjected to confirmatory analysis.
The final report shall be based on the confirmatory results.
 The screening laboratory shall be only the authorized laboratory to
release final result.
 All laboratory reports shall bear the signature of the analyst and the Head
of the laboratory.
 All test results are reported using the DOH standard electronic laboratory
form.
 No result is relayed through telephone.
When the laboratory reports an invalid result due to the possible presence of an
unidentified interfering substance/adulterant, the Head of the Laboratory shall:
 Send the specimen to another DOH accredited laboratory capable of
identifying the interfering substance/adulterant.
 Report the result as “Test Cancelled” if the explanation provided by the
Client/Donor is:
1. Acceptable, then an immediate direct observed collection is not
required.
2. Not acceptable, then an immediate direct observed collection is
required.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Procedure for Security and Confidentiality of Records, Supplies and
Specimen
 The laboratory controls the access of unauthorized individual and ensure
that no unauthorized individual can gain access to specimen and records.
 The screened result of the drug test, either positive or negative, is treated
with strict confidentiality.
 Only assigned personnel who are trained to keep the record with firm
confidentiality will give the report or result.
 All screened results are written on logbooks with the analyst’s signature.
 Specimen should be properly sealed with proper affixes of signatures
both by ASC and client/donor.
 All screened negative specimen are kept refrigerated for five days until
disposal.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Storage and Disposal of Specimen
 Urine specimen are stored at 2-8 degree celcius.
 Screened negative results are stored up to 5 days before discarded.
 Screened positive results are sent to confirmatory testing.
 Judicial proceedings or upon request of screened results are stored up to
one year.
 If test is not performed immediately, specimen may be refrigerated for up
to 48 hours. For longer storage, samples may be frozen.
 All specimen are discarded by flashing in a toilet bowl.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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 Internal Quality Assurance Program
 The use of drug test kits is first validated with the DOH regional
office.
 Purchase only on drug test companies accredited by FDA.
 Keep record on used and unused kits in the separated form- the Drug
test Validation form.
 A positive and negative control is tested to assure the quality of every
batch and lot number of kits that have previously been validated.
 Three tests may be performed with each batch of kits.
a. A control with no drug metabolite.
b. A control that has metabolite of 25% below cut off value.
c. A control that has metabolite at 25% below cut off value.
 Record the results in the testing of controls in a corresponding logbook
indicating the lot number, expiry date, signature of the analyst, date
and time of testing. This is an evaluation of the test kits if it if suitable
for used.
External Quality Assurance Program
The NRL conducts a PT (Proficiency Testing) for screening of DTLs.
1. PCC Health Diagnostics Center participates in the PT as required for
renewal of Drug Test license with the procedure as follow:
a. Submit to NRL a letter of intent for PT, properly accomplished
application form and payment prior to the scheduled PT.
b. The application form must be filled up with the administrative and
analytical procedures.
2. Upon receipt of 10 unknown samples containing Methamphetamine and
Tetrahydrocannabinol in various concentrations from NRL, fill up the
acknowledgement form that accompanies the samples.
a. The samples were shipped with intact and sealed pouch.
b. Each sample in the vial appears to be urine samples in color (yellow to
orange)
c. Each sample is labeled legibly.
d. Each sample vial is sealed tightly.
e. Each sample vial contain 3 ml volume sample.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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In case there is NO answer in any of the above, call NRL-EAMC immeadiately
to inform them of the condition of the samples received.
3. Test all samples as we do to our drug test client samples under regular
procedures and conditions.
4. Submit the completed result form within 48 hours of receipt of the
samples through mailing:
National Reference Laboratory
East Avenue Medical Center
East Avenue, Diliman, Quezon City 1101
5. Submit online the completed result form within 48 hours to
www.nrleamcdoh.org
6. To ensure confidentiality in the conduct of the PT samples, check that the
laboratory ID code and PT sample codes in the sample tubes does tally
with all the information attached in the PT document. If there are
discrepancies, call NRL immediately.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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Good Laboratory Practice

 Laboratory Gown and gloves are to be worn during the processing of

urine.
 Dispose waste materials in properly labelled waste containers, all
personnel should practice waste segregation.
 Containers that are recycled are immersed in disinfectant solution,
rinsed, and air dried.
 Eating and Drinking should be at a proper designated area.
 Avoid spillage of urine specimen for a cleaner working area.

Prepared by: Approved by:

Malyka C Capital, RMT Ponciano S. Limcangco, M.D.,FPSP

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