Ra 9165 Handout-E Drug & Drug Testing

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Handouts (MT)-E
RA 9165
The Comprehensive Dangerous Drugs Act of 2002
RA 9165 Comprehensive Dangerous Drugs Act of 2002
January 23, 2002
Repealing RA 6425, otherwise known as the Dangerous Drugs Act of 1972
Declaration of Policy
It is the policy of the State to safeguard the integrity of its territory and the well-being of its citizenry particularly the youth, from
the harmful effects of dangerous drugs on their physical and mental well-being, and to defend the same against acts or
omissions detrimental to their development and preservation.
Administer
Act of introducing any dangerous drug into the body of any person, with or without his/her knowledge, by injection, inhalation,
ingestion or other means, or of committing any act of indispensable assistance to a person in administering a dangerous drug
to himself/herself unless administered by a duly licensed practitioner for purposes of medication.
Analyst
Refers to the professional who perform the drug testing.
Certified Drug Analyst:
Medical Technologist
Chemist
Chemical Engineer
Pharmacist
Authorized Specimen Collector
A person who is authorized to collect specimen from the client to secure and prevent alteration of Urine specimen.
1. Must be at least high school graduate
2. Must have undergone appropriate training
Chain of Custody
The procedure to account for each specimen by tracking the handling and storage from point of collection to final disposal. It
procedure require that the applicants identity is confirmed and that a chain of custody form that is used from the time of
collection to receipt by the laboratory. A form is used to document the procedures from the time of collection until receipt by
the laboratory.
Dangerous Drugs
There are hundreds of Dangerous drugs, but the most important and the most common tested in screening laboratory is:
a. Methamphetamine (Shabu)
b. Tetrahydrocanabinol (Marijuana)
Other parameters that are tested includes:
a. Ecstacy
b. Opium
c. Cocaine
d.
National Reference Laboratory
1. East Ave. Medical Center
The National Reference Laboratory for environmental and Occupational Health, Toxicology and Micronutrient assay
Other National Reference Laboaratory:
2. RITM Dengue, influenza, TB and other Mycobateria, Malaria and other parasites, Bacterial Enteric diseases, measles, and other
Viral exanthems, Mycology, Enterovirus, Antimicrobial resistance and emerging diseases for confirmatory testing for blood
donor units (HIV)
3. San Lazaro Hospital HIV (Serological test), Hepatitis and other STD
4. National Kidney and Transplant Institute Hematology including Immunohematology
Screening Test
A rapid test performed to establish potential/presumptive positive result.
Qualitative test.
Specimen
Refers to the body fluid that is collected from a person.
Classification of Drug Testing Laboratory

Ownership:
Government
Private
Institutional Character:
Institutional Based
Freestanding
Service Capability:
Screening Laboratory
Confirmatory Laboratory
Mandatory Drug Testing

Applied to the following
1. Applicants for Drivers License
2. Applicants for Firearms License
3. Officers and members of the military, police and other law enforcements
4. Candidates for Public Office
5. Persons charged before the prosecutors office with criminal charge offense having am impossible penalty of
imprisonment of not less than 6years and 1day
6. Persons apprehended for the violations of this act
Random Drug Testing
Applied to the following
1. Students of Secondary or Tertiary schools
2. Officers and employee of public and private and private offices whether domestic or oversees.
REQUIREMENTS FOR ACCREDITATION

A. Bureau of Health Facilities and Services
The certificate of accreditation, shall state the name of owner and head of the laboratory, the classification and validity of
period. The certificate shall be valid for a period of 1 year for Screening Laboratory and 2 yrs for Confirmatory Laboratory
Certificates shall be signed by the BHFS or CHD director
B Technical Requirements for Licensing

Physical Plant
1. Screening Laboratory
At least 20 sqm in floor area
The work area must be at least 10 sqm with exhaust fan, sink, and storage cabinet, and a ref.
2. Confirmatory Laboratory
At least 60sqm in floor area
The clinical work area must have at least 30sqm with exhaust fan, sink, stock room and instrumentation room
A Laboratory of whatever category shall have within its premises an area which can receive or accommodate at least 5 client
at a time.
With a hand washing facility, Toilet facility, and a stall for the collection of the specimen
Headship of the Laboratory

a. Screening laboratory
1. Shall be headed by a licensed physician with certification in Clinical Pathology or certification in Clinical Laboratory Management
training conducted by the DOH. The maximum number of screening laboratories a physician trained in clinical laboratory
management can handle is 10, provided they are physically feasible (within 5 km radius) to supervise.
2. in cases where the screening drug-testing, laboratory is a division, section or unit of a clinical laboratory, it shall be headed either
by a licensed physician, chemist, medical technologist, pharmacist or chemical engineer.
b. Confirmatory Laboratory
1. Shall be headed by a licensed physician certified in Clinical Pathology with at least 2 years of active laboratory experience in
analytical toxicology; or
2. licensed chemist with at least a Master's degree in Chemistry, Biochemistry or a branch of Chemistry and at least 2 years of active
laboratory experience in analytical chemistry.
Laboratory Equipment
Screening Laboratory shall have a necessary equipment or kit.
Confirmatory Laboratory shall have a necessary equipment for screening, qualitative and quantitative examination in addition to the
basic equipment.
Application Service Provider
The Laboratory shall have access to an Application Service Provider approved by the DOH for the authentication of results.
Records
The Laboratory shall maintain a record of all of its personnel. The records must include the resume, training and experience,
certification, PRC license, incident report (if any) and other information, which will established the competence of an
employee.
Security
The laboratory shall have security measures to control access to the premises to ensure that only authorized personnel
handle or have access to specimens or gain access to the lab.
Chain of Custody
The minimum required information on the Chain of Custody are:
1. Information identifying the specimen
2. Date and time of the specimen
3. Name of the testing laboratory
4. Name of the signatures of all individuals who had custody of the samples during the collection process.
Technical Requirement for Accreditation

Storage of Laboratory Reports and Specimens
TYPES OF SPECIMEN VOLUME

1. Blood Minimum of 5 ml (w/o anticoagulant)
2. Fingernails To be determined
3. Tissue To be determined
4. Sweat (patch) 1 DOH cleared patch worn for 7-14 days
5. Saliva (Oral fluid) 2 ml
6. Scalp hair 100 mg hair (1 cm. Above the scalp)
7. Urine 60 ml (in single container)/ 30 ml each container
Storage of Laboratory Reports and Specimens

Report pertaining to specimens for laboratory report shall be kept by the testing laboratory for a minimum period determined
by DOH (1 year)
A laboratory must retain a specimen that was reported as negative (-) for a minimum of 5 days after receipt of result.
A laboratory must retain a specimen that was reported positive (+), adulterated, substituted or invalid for a minimum of 15
days after receipt, shall be discarded.
A laboratory must retain all records generated to support test results for at least 2 years
All other records associated with positive (+) results or a specimen under legal challenge shall be maintained for an indefinite
period.
Urine Specimen Collection, Handling and Disposal

The Laboratory shall follow the DOH prescribed guidelines in the collection, handling and disposal of specimens.
Universal precautions must be observed at all times.
1. Yellow Infectious waste such as gauze pad contaminated with urine specimen
2. Green Biodegradable waster (food waste)
3. Black Non-biodegradable waste (paper, office supply waste)
Equipment and instruments:
1 .Screening Laboratory:
1. Drug Testing Kits
2. Confirmatory Laboratory:
1. Weighting scale
2. Glassware's used in testing (beaker, Erlenmeyer flask, pipettes)
3. Automatic pipettes
4. Chromatographs
5. Spectrometer/Mass Spectrometer
6. Biological Safety Cabinet
Laboratory Report
Signatory must be the analyst who performed the test. And also the head of the Laboratory.
For screening, the test result must be reported as POSITIVE OR NEGATIVE.
For Confirmatory, the test result shall report the analyte and the concentration.
All specimen with positive (+) screening test results shall be submitted for confirmation before final report will be issued.
2 two copies must be produced:
- 1 copy for the client
- 1 copy must be forwarded to DOH and must include the membrane of the drug test kit in the case of screening
tests and a copy of the chromatogram in the case of confirmatory tests.
Proficiency Testing
NRL shall conduct a continuing assessment of proficiency of the Screening and Confirmatory Laboratory. Participation of the
laboratory is important and also must be satisfactorily passed the testing in order for the laboratory to renew their license.
The results must sent back to NRL within 3 weeks after the results.
Failure to pass the proficiency testing shall be given another chance, failure to pass the second one shall result in revocation
of its license and accreditation
Drug Testing Result

Unlike pregnancy test result, a negative drug test result indicates a presence of line, and
a positive result is an absence of line.
Validity of the Test Result

A drug certificate is valid for 1 year from the date of issue. Which may also be used for other
purpose.
Allowable Service Fee
P 300 Private Hospital/Free Standing Laboratory
P 250 Public Hospital
Licensing and Accreditation

The following must be submitted to DOH via BHFS before certificate of accreditation and license to operate is given:
1. License to Operate
2. BHFS application form
3. Mayors Permit
4. 1 set of floor plan
5. List of personnel, list of credentials, health certificate
6. List of Equipments
7. Contract of License (if facility is rented)
8. Copy of DOH license to operate
9. Documentation of CCF
Quality Control Program (Screening Laboratory)

Certification for Quality Control Standard System by a DOH recognized certifying body (Confirmatory Laboratory)
Proficiency Testing Result
Procedure Testing Manual
Content of License to Operate

1. Name of the owner
2. Head of the Laboratory
3. Procedures and Specialty
4. Validity Report
5. Signature of the Bureau or CHD Director
Renewal of LTO/COA
It shall be filled 90 days before the expiration of license
License to Operate
Application for renewal
Notarized List of Personnel
List of Equipments
Current Certificate of Accreditation
Current Mayors Permit
Certificate of Accreditation
Current license to Operate
Current Certification for Quality Standard System (Confirmatory Laboratory)
Monitoring of Laboratories
The bureau or the CHD may conduct a visit on the site (Laboratory) unannounced. And the monitoring shall be documented
the overall quality of the laboratory setting.
Terms and Conditions of Licensing/Accreditation

License/accreditation shall be granted in accordance with the prescribed requirement of the DOH
A license/accreditation that is not renewed on the expiry date shall be considered lapsed and will be cancelled.
Any change in management name or ownership, floor plan, reliever, equipment, etc shall be reported to the DOH via BHFS.
License/Accreditation shall be placed in an area where it is seen by the client
Violations
1. Issuance of fraudulent result
= penalty of imprisonment from 6 yrs and 1 day to 12 years
= fine ranging from 100,000 - 500,000
2. Failure to protect the confidentiality of a drug test result
3. Failure to participate in a proficiency testing
4. Failure to refer a positive result to a confirmatory laboratory.
5. Refusal to CHD to inspect their laboratory
6. Any act which is contrary to the accepted clinical laboratory practice.
Suspension or Revocation of LTO/COA

Based on its own inspection of any complaint, it shall be investigated and after due hearing, and depending on the judgment.
Revocation or suspension of the license will be done.
If any violation is done (under section 17) preventive suspension shall be done. And should not be more than 60days
Reapplication for LTO/COA

A Laboratory whose certificate of accreditation has been revoked may be reapply for the issuance of a new one upon
compliance with the requirements established hereunder and/or the correction of the deficiency or violation.

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MTLBE

Classification of Drug Testing Laboratory

Mandatory Drug Testing

REQUIREMENTS FOR ACCREDITATION

B Technical Requirements for Licensing

Headship of the Laboratory

Technical Requirement for Accreditation

TYPES OF SPECIMEN VOLUME

Storage of Laboratory Reports and Specimens

Urine Specimen Collection, Handling and Disposal

Drug Testing Result

Validity of the Test Result

Licensing and Accreditation

Quality Control Program (Screening Laboratory)

Content of License to Operate

Terms and Conditions of Licensing/Accreditation

Suspension or Revocation of LTO/COA

Reapplication for LTO/COA

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