DRUG TESTING IN THE PHILIPPINES PDF

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DRUG TESTING IN THE PHILIPPINESThe best practices for drug testing in the Philippines are based on the generalprinciples that have been established internationally. They are designed toensure that the entire drug testing process is conducted to give accurate andreliable information about client/dono...

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DRUG TESTING IN THE PHILIPPINES The best practices for drug testing in the Philippines are based on the general principles that have been established internationally. They are designed to ensure that the entire drug testing process is conducted to give accurate and reliable information about client/donor/subject’s drug use. Background Republic Act 9165 otherwise known as the “Comprehensive Dangerous Drugs Act of 2002” mandates the Department of Health to oversee and monitor the integration, coordination and supervision of all drug rehabilitation, intervention, after-care and follow-up programs, projects and activities as well as the establishment, operation, maintenance and management of privately-owned drug treatment rehabilitation centers and drug testing networks and laboratories throughout the country, in coordination with DSWD and other agencies. The responsibility of the DOH, through the Bureau of Health Facilities and Services (BHFS, formerly the Bureau of Licensing and Regulation), is to license and accredit drug-testing laboratories (DTL) to assure the quality, competence and integrity in the conduct of drug testing. The East Avenue Medical Center is designated as the National Reference Laboratory (NRL) for Environmental and Occupational Health, Toxicology and Micronutrient Assay by virtue of Department Order No. 393-E s. 2000. The NRL in coordination with BHFS shall assure the competence, integrity and stability of drug testing centers nationwide. 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. Scope This covers all accredited government and private drug testing laboratories in the Philippines. Functions The BHFS is mandated to formulate and establish the standards for regulation of hospitals, clinics and other health facilities and to enforce standards that shall be the basis of issuance of license/accreditation of a facility. In accordance with this mandate, BHFS shall be tasked to:

a) Develop policies and guidelines on establishment, operation and monitoring of drug testing laboratories. b) Conduct accreditation of all private and government drug testing laboratories. c) Conduct training of DOH regulatory officers. d) Conduct research and development of drug testing and other related activities The NRL for Environmental and Occupational Health, Toxicology and Micronutrient Assay is mandated with the following functions: a) Develop comprehensive procedural and scientific standards for all aspects of drug testing program. b) Promote quality assurance program in all drug testing laboratories. c) Assist DOH designated agencies in the conduct of accreditation of confirmatory laboratories for drug testing and in the evaluation of test kits and reagents. d) Resolve conflicting/challenge results among confirmatory laboratories. e) Train technical staff of drug testing laboratories. f) Conduct research and development of drug testing and other related activities. LABORATORY PERSONNEL The laboratory must have suitable qualified personnel. DTL Owner

Head of Laboratory

Technical Personnel Analyst Authorized Specimen Collector Laboratory Aide

Organizational Chart Qualifications of Personnel Head of the Laboratory 1. In a Screening Laboratory must be

Administrative Personnel Clerk Secretary

a) a licensed physician certified in Clinical Pathology by the Philippine Board of Pathology; or b) a licensed physician trained in laboratory management and drug testing operation. 2. In a Confirmatory Laboratory must be a) 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 b) 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: a) Theory and practice of the drug testing procedures used in the laboratory; b) Chain of custody, reporting, and record keeping; c) Review and interpretation of test results; d) Quality assurance program; and e) Dangerous drugs regulations and policies. The Head of the Laboratory has the following functions and responsibilities: 1. Administrative a) Has general and overall supervision of the facility and all aspects of laboratory work; b) Has general supervision and conduct of all laboratory personnel; c) Formulates and implements standard operation manual that govern the operation of the DTL. This shall be periodically reviewed and updated; d) Prepares financial and annual reports of the laboratory; e) Provides other administrative support services such as communications, security and maintenance services. 2. Technical a) Supervises and directs all analytical procedures of the laboratory; b) Assures quality of all laboratory test results; c) Issues, signs out and interprets laboratory results;

d) Evaluates and recommends reagents, supplies and equipment; e) Reviews the CCF and reports received from authorized collector; f) Interviews the Client/Donor/Subject, if necessary; g) Reviews pertinent medical records of Client/Donor/Subject, if necessary; h) Cancels the results of all specimen which are not collected or tested not in accordance with the DTL manual; i) Reviews, rejects, and refers for confirmation and retesting all specimen and test results that are positive, adulterated, substituted or invalid; j) Implements remedial actions necessary to maintain satisfactory operation and performance in the laboratory; k) Directs protocol for preventive maintenance of equipment; l) Provides comprehensive, continuing training and education of personnel related to conduct of DTL. Analyst The personnel must be a registered 1. Chemist 2. Chemical Engineer 3. Medical Technologist 4. Pharmacist The analyst must have training in the following: a) Analytical methods and procedures; b) Maintenance of chain of custody; c) Reviewing and reporting test results; d) Proper remedial action in response to problems that may arise; e) Quality control procedures and practices; f) Dangerous drugs regulations and policies. The functions and responsibilities of the analyst are as follows: a) Verifies the completeness of Custody and Control Form (CCF); b) Prepares specimen for analysis; c) Examines, processes and analyzes specimen for drug testing; d) Interprets, records, releases and signs out laboratory results; e) Assists in the implementation of quality assurance program; f) Assists in the evaluation of reagents, supplies and equipment; g) Refers to the Head of the Laboratory as the need arises. Authorized Specimen Collector There shall be a designated authorized personnel within the laboratory to collect the specimen who must

1. Be at least a high school graduate 2. Have undergone appropriate training An Authorized Specimen Collector must have undergone training in: a) Collection procedure for each type of specimen; b) Chain of custody and record keeping; c) Specimen integrity and security; and d) Dangerous drugs regulations and policies. Retraining of Authorized Specimen Collector shall be required under the following conditions: a) The collection procedure changes significantly (e.g., a new CCF is used); or b) 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: a) Restricts unauthorized personnel to enter the collection site during collection; b) Verifies identity of the Client/Donor/Subject; c) Provides security to specimen supplies, records and documents at collection site; d) Informs the Client/Donor/Subject the procedures of specimen collection; e) Performs only one specimen collection at a time; f) Accepts and seals the specimen container in the presence of the Client/Donor/Subject; g) Accomplishes CCF. The following are persons who are not authorized to collect specimen: a) Employer of the Client/Donor/Subject b) Investigator at the crime scene c) Complainant d) Owner/Administrator of establishment Other Laboratory Personnel 1. Each personnel must have the educational background appropriate for the tasks assigned. 2. Each personnel must have appropriate training and preferably with experience.

Evaluation and Personnel Development 1. The laboratory must establish criteria for evaluation of performance of all personnel. 2. 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. 3. The Head of the Laboratory must evaluate the performance of all personnel as the need arises. FACILITIES AND EQUIPMENT REQUIREMENTS Floor Plan A Screening Laboratory shall have at least twenty (20) square meters in floor area. The work area must be ten (10) square meters with an exhaust fan, sink and storage cabinet. A Confirmatory Laboratory shall have at least sixty (60) square meters in floor area. The clinical work area must be thirty (30) square meters with exhaust fan, sink, fume hood, stock room and instrumentation room. A laboratory of whatever category shall have within its premises an area, which can receive or accommodate at least five (5) prospective Client/Donor/Subjects at a time, a hand-washing facility, toilet facility, and stall for the orderly collection of specimen. A DOH-accredited hospital or non-hospital based Secondary or Tertiary Category Clinical Laboratory which intends to put up a Screening Laboratory for Drug Testing need not provide an additional twenty (20) square meters to its existing floor area. It shall only designate an area for drug testing within the clinical laboratory. Equipment/Maintenance/Supplies and Materials Collection Device The collection device considered for the following types of specimen collected: Chapter .3 FACILITIES AND EQUIPMENT REQUIREMENTS

3.1 Floor plan 3.1.1 Screening Laboratory- shall have at least twenty (20) square meters in floor area. The work area must be ten (10) square meters with an exhaust fat, sink, and storage cabinet. 3.1.2 Confirmatory Laboratory- shall have at least sixty (60) square meters in floor area. The clinical work area must be thirty (30) square meters with exhaust fan, sink, fume hood, stock room and instrumental room. A laboratory of whatever category shall have within its premises an area, which can receive or accommodate at least five (5) prospective Client/Donnor/Subjects at a given time, a hand washing facility, toilet facility, and stall for the orderly collection of specimen. A DOH-accredited hospital or non-hospital based Secondary or Tertiary Category Clinical Laboratory which intends to put up a Screening Laboratory for Drug Testing need not provide an additional twenty (20) square meters to its existing floor area. It shall only designate an area for drug testing within the clinical laboratory. Refer to Figures 2 and 3 (Prototype of Floor Plan). 3.2 Equipment/Maintenance/Supplies and Materials 3.2.1 Refer to Table 2, page 166 (Table to Technique/ Equipment/Glassware/Reagents/Supplies and Materials) 3.2.2 Collection Device The collection device considered for the following types of specimen collected: (a) For urine specimen: Screw capped, wide mouth, 30 or 60mL capacity polyethylene specimen container. (b) For scalp hair specimen: Self-sealing transparent plastic bag, 200 mg capacity. (c) For oral fluid (saliva) specimen: Screw capped wide mouth 30mL capacity polyethylene specimen container. (d) For sweat specimen: patch placed on the skin and transferred in a container with suitable transport medium. (e) For blood: 10 ml capacity plain test tube. (f) For tissue: specimen immediately frozen and transported placed in clean, dry, tightly capped plastic container with no additives. (g) For fingernails: Self-sealing transparent plastic bag, 200 mg capacity. Note: (i) The collection device shall not affect or alter the specimen collected. (ii) All specimen containers shall be properly labeled and sealed. (iii) If the collection device is unique and integral part of the collection and analytical testing procedure, it must be registered by an appropriate agency designated by DOH as a medical device (e.g., the sweat patch) (iv) Single-use items are not unique collection devices and are not required to be cleared by the DOH. 3.2.3 Calibration and Maintenance Properly functioning equipment is essential for accurate testing. The equipment maintenance and calibration record shall document that all instruments are properly maintained, calibrated, cleaned and monitored.

3.2.3.1 All equipment must be calibrated and maintained according to the procedures in the manufacturer’s manual. 3.2.3.2 There shall be a record indicating that the equipment has been calibrated and/ or checked on a regular schedule based on established procedures. 3.2.3.3 Trained personnel should be assigned to calibrate equipment regularly. 3.2.3.4 Corrective actions and recommendations must likewise be documented when instruments fail to function as expected. 3.2.3.5 Contents of calibration/maintenance record: (a) (b) (c) (d) (e) (f) (g) (h) (i)

Name of instruments, 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 Name of authorized person who performed the calibration/ maintenance of equipment.

3.3 Lighting and Ventilation There shall be adequate lighting and ventilation in all work areas. Chapter 4 COLLECTION SITE There shall be a designated space or area for collection of specimen: 4.1 It shall be a designated area within the laboratory or a temporary facility located at a remote site. 4.2 The selection of an appropriate collection site will depend on the type of specimen being collected. 4.3 A collection site must have the following: 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.4

A suitable clean surface for handling the specimen and completing the required paperwork; A secured temporary storage capability to maintain a specimen until it is tested or shipped to the laboratory. An area to provide Client/Donor/Subject privacy appropriate to the specimen being collected (e.g., toilet); A controlled and secured area for supplied and records; A poster or information bulletin with a detailed description of the proper specimen collection processes. 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: 4.4.1 Workplace/school/jail or prison/ rehabilitation center for: 4.4.1.1 Random 4.4.1.2 Follow-up

4.4.1.3 Reasonable suspicion/cause 4.4.1.4 Crime scene and post accident 4.4.2 Person who are critically ill/disabled 4.5 Collection of specimen for all mandatory drug testing (e.g., driver’s license, R.A. 9165) shall be done at a permanent facility except for crime scene and post accident. 4.6 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. 4.7 No examinations must be conducted at a temporary collection facility. Note: Refer to Appendix J (BHFS Bureau Circular No. 09 s. 2003 re: Guidelines for Remote Collection for Drug Testing Specimen)

Chapter 5

SPECIMEN The NRL shall evaluate the protocol for each type of specimen. 5.1 Types of Specimen A Drug Testing Laboratory may collect: 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 5.2

Blood Fingernails Saliva (oral fluid) Scalp Hair Sweat (Patch) Tissue Urine

Reason for Test 5.2.1 Blood 5.2.2 Fingernails 5.2.3 Scalp Hair

: : :

Reasonable suspicion/ cause reasonable suspicion/ cause Pre-employment, random, return to duty, follow up 5.2.4 Saliva (Oral Fluid) : Pre-employment, random, reasonable suspicion/cause 5.2.5 Sweat (patch) : Return to duty, follow up 5.2.6 Tissues : Reasonable suspicion/cause 5.2.7 Urine : Pre-employment, random, reasonable suspicion/cause, mandatory 5.3 More than one type of specimen maybe collected at same time from the same Client/ Donor/ Subject. 5.4

A 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.

5.5

The minimum quantity of specimen to be collected: 5.5.1 5.5.2 5.5.3

Blood Fingernails Scalp Hair

5.5.4 5.5.5

Tissue : Saliva (Oral Fluid)

5.5.6 5.5.7

Sweat Urine

: : :

Minimum of 5 mL To be determined 100 mg hair (or its equivalent in number of strands or 1 cm. Abov the scalp) To be determined : 2 ml collected as a “neat” specimen (divided as follows: at least 1.5 mL the primary specimen and at least 0.5 mL for the challenge test) : :

1 “patch” worn for 7 to 14 days 60mL in single container or 30 mL each in two separate containers for split specimen.

Note: (I) (II)

The type and quantity of specimen listed above may vary depending on the existing technology. Specimen may be collected using single container, however, split specimen collection maybe done upon request if situation permits.

5.6

Handling and Storage Proper handling and storage of specimen must be taken to ensure the integrity of the drug and/or metabolite. 5.6.1

Blood

:

5.6.2 5.6.3 5.6.4 5.6.5 5.6.6 5.6.7

Fingernails Scalp hair Tissue Saliva Sweat Urine

: : : : : ;

separate serum then immediately freeze specimen to be determined stored at cool and dry place macerated and frozen. deep-frozen at least- 8 to 10OC to be determined prolonged storage at –20OC

Note: Urine maybe stored initially in the refrigerator between 2-6OC, for not more than 1 day. 5.7

Transport Specimen 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: 5.7.1 5.7.2

5.7.3 5.7.4 5.7.5

Minimize the number of personnel handling the specimen. Document the date and the purpose on the CCF each time a specimen is handled or transferred. Identify each person who handled the specimen. When courier services are utilized, the time of receipt from the collection site and the time of delivery to the laboratory must be documented on the CCF. Place specimen in sealed transparent plastic bag and an appropriate transport container designed to minimized damage, and seal them securely to eliminate the possibilities of tampering. Ensure that the CCF accompanies the appropriate specimen transport container. 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 record and report any apparent tampering with the container or specimen, any discrepancy in the specimen and the CCF.

Chapter 6 LABORATORY PROCEDURE FOR SPECIMEN HANDLING A DOH- accredited laboratory must have a standard operating procedure (SOP) manual that describes, in detail, all laboratory operations pertaining to specimen handling. When followed, it ensures that all specimen are tested using the same procedure...