Licensing of Dangerous Drug Testing Laboratories and Prescribing Standards for Their Operation

2000

DANGEROUS DRUGS BOARD REGULATION NO. 1-00

LICENSING OF DANGEROUS DRUG TESTING LABORATORIES AND PRESCRIBING THE STANDARDS FOR THEIR OPERATION

In the interest of the service and pursuant to Section 36 (a) and 24-A of Republic Act No. 6425, "The Dangerous Drugs Act of 1972", as amended, the following rules and regulations are hereby promulgated to govern the establishment, operation and maintenance of drug testing laboratories: acTDCI

I. General Provisions

SECTION 1. Definition of Terms. — As used in this Guidelines, unless the context otherwise requires:

a. "Act" refers to Republic Act No. 6425, "The Dangerous Drugs Act of 1972", as amended;

b. "Board" refers to the Dangerous Drugs Board created under Section 35 of the Act;

c. "Dangerous drugs" or "drugs" refers to prohibited and regulated drugs as defined in Section 2, Article 1 of the Act, and shall include controlled substances;

d. "Specimen" refers to the body fluid that is collected from a person;

e. "Donor" refers to the individual from whom a specimen is collected;

f. "Laboratory" refers to a private or government agency that is capable of testing a specimen to determine the presence of dangerous drugs, therein;

g. "License" refers to the authority granted by the Board to operate and maintain a laboratory;

h. "Applicant" refers to a laboratory that is applying for the issuance of a license;

i. "Licensee" refers to a laboratory that is issued a license;

j. "Chairman" refers to the Chairman of the Board;

k. "Executive Director" refers to the Executive Director of the Board;

l. "Drug Identification Analysis Professional" or "DIAP" refers to a licensed medical technologist, pharmacist or chemical engineer who has undergone intensive training on the conduct of laboratory examinations/tests to identify dangerous drugs on a specimen; TEHDIA

m. "Screening test" refers to the immunoassay test to eliminate a "negative" specimen i.e. one without the presence of drugs from further consideration and to identify the presumption positive specimen that requires confirmation or further testing; and

n. "Confirmatory test" refers to the second or further analytical procedure to identify the presence of drugs in a specimen.

II. Categories of Laboratories

SECTION 2. Categories of Laboratories. — There shall be three categories of drug testing laboratories, to wit —

a. Class A. — This laboratory shall be capable of conducting screening and confirmatory tests and the quantitative examination of specimens.

b. Class B. — This shall be capable of performing screening and confirmatory tests.

c. Class C. — This shall only be capable of conducting screening tests.

SECTION 3. Laboratory Equipment. — A laboratory shall be required to have the following equipment:

a. Class A — This shall have the following instruments —

i. For screening tests — Immunoassay Equipment and Validated Drug Testing Kit

ii. For confirmatory tests — Thin Layer Chromatograph

iii. For Quantitative Examination — Mass Spectrometer-Gas Chromatograph (GC-MS) and High Performance Liquid Chromatograph (HPLC)

iv. Basic equipment

— Laboratory Oven

— Sample Concentrator

— Centrifuge

— Water Bath

— Weighing Scale

— Shaker

— Refrigerator

— Freezer

b. Class B —

i. For screening tests — Immunoassay Equipment and Validated Drug Testing Kit

ii. For confirmatory tests — Thin Layer Chromatrophy

iii. Basic equipment — same as Class A Laboratory

c. Class C —

For screening tests — Immunoassay Equipment and/or Validated Drug Testing Kit.

SECTION 4. Laboratory Facilities. — A laboratory shall comply with all government building regulations and shall have the following spatial dimensions and facilities:

a. Class A — This shall have at least one hundred (100) square meters with instrumentation room, work (wet) area, fumehood, storage cabinet and wash room;

b. Class B — This shall have at least forty (40) square meters with a work (wet) area, fumehood, storage cabinet and wash room; and

c. Class C — This shall have at least twenty (20) square meters with a work area, exhaust fan, lavatory, storage cabinet and wash room.

SECTION 5. Receiving Area. — A laboratory of whatever Class shall have within its premises an area which can receive or accommodate at least twenty (20) prospective donors at a given time, and a lavatory, stall or other partitioned area for the orderly collection of specimens.

SECTION 6. Staff of Laboratories. — A laboratory shall have the following technical staff who may also be its head:

a. Class A — This shall have a licensed chemist and medical technologist of pharmacist or chemical engineer or one who has successfully completed training in chromatography;

b. Class B — This shall have a licensed chemist, medical technologist/pharmacist or one who has successfully completed training in chromatography; and

c. Class C — this shall have a licensed medical technologist/pharmacist or a chemical engineer.

Class A and B laboratories shall have qualified personnel who can testify in any administrative, criminal or other proceeding on the results of laboratory test.

SECTION 7. Other Laboratory Personnel. — A laboratory shall have such non-technical personnel who shall have the necessary training and skills for the tasks assigned to them. The staff of Class A and B laboratories shall be required to pass a proficiency test to be established by the Board.

SECTION 8. Laboratory Manager; Qualifications. — A laboratory shall be headed by a licensed chemist, medical technologist, pharmacist or chemical engineer who has experience or training in the theory and practice of the procedures used in the laboratory, resulting in his or her thorough understanding of quality control procedures and practices; the review, interpretation and reporting of test results; the maintenance of chain of custody; and of proper remedial actions to be taken in response to test systems being out of control limits or quality control results. STaCIA

III. Other Requirements

SECTION 9. Records of Laboratory Personnel. — The laboratory shall maintain a record of all its personnel. These records shall include the resume of training and experience; the certification or license, if any; incident reports; and such other information which establish the competence of the employee.

SECTION 10. Security. — A laboratory shall have such security measures to control access to the premises and to ensure that only authorized personnel handle or have access to specimens or can gain access to the laboratory processes or to areas where records are stored. With the exception of duly authorized representatives of the Board, all authorized visitors and maintenance and service personnel shall be escorted at all times while inside the laboratory. The laboratory shall maintain a record that indicates the dates, time of entry and exit and purpose of entry of non-employees.

SECTION 11. Chain of Custody. — A laboratory shall use chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results, during storage and continuing until final disposition of the specimens. The date and purpose shall be documented on an appropriate chain of custody form each time a specimen is handled or transferred, and every individual in the chain shall be identified. Accordingly, authorized technicians shall be responsible for each specimen in their possession and shall sign and complete chain of custody forms therefor.

SECTION 12. Storage of Records and Specimens. — All records pertaining to specimens shall be kept by the testing laboratory for a minimum period of two (2) years. The specimens in positive test results which are not challenged within fifteen (15) days upon receipt by the donor of said results shall be discarded. CAaDTH

SECTION 13. Test Levels. — The Board shall require each laboratory to submit its protocol indicating the initial cut-off levels in screening specimens to determine whether they are negative or for confirmation of the presence of dangerous drugs. The acceptability of the cut-off levels shall depend on the capability of the laboratory, its equipment and validated testing kits.

SECTION 14. Procedure Manual. — A laboratory shall have a procedure manual which shall include the principals of each test, the preparation of reagents, standards and controls, calibration procedures, derivation of results, linearity of methods, sensitivity of the methods, cut off values, mechanisms for reporting results, controls criteria for unacceptable specimens and results, remedial actions to be taken when the test systems and results, remedial actions to be taken when the test systems are outside of acceptable limits, reagents and expiration dates and references. Copies of all procedures and dates on which they are in effect shall be maintained as part of the manual.

SECTION 15. Calibrators and Controls. — Laboratory calibrators and controls shall be prepared using pure drug reference materials, stock standard solutions obtained from other laboratories, or standard solutions obtained from commercial manufacturers. The calibrators and controls shall be properly labeled as to content and concentration. The standards (e.g., pure reference materials, stock standard solutions, purchased standards) shall be labeled with the following dates: when received (if applicable); when prepared or opened; when placed in service; and expiration date.

If a laboratory uses testing kits, the test reagents shall be validated and licensed by the Board and registered with the Bureau of Food and Drugs.

SECTION 16. Instruments and Equipment. — Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by gravimetric, colimetric, or other verification procedure. Automatic pipettes and dilutors shall be checked for accuracy and reproducibility before being placed in service and checked periodically. Thereafter, there shall be written procedures for instrument set-up and formal operations, a schedule for checking the critical operating characteristics for all instruments, tolerance limits for acceptable function checks, and instructions for major troubleshooting and repair. Preventive maintenance records shall be kept.

 

IV. Application for License

SECTION 17. Application, Where Filed. — An application for a license shall be filed with the office of the Executive Director. DcHaET

SECTION 18. Form of Application; Supporting Documents. — An application shall be in the form prescribed by the Board. It shall be signed by an authorized representative of the applicant and placed under oath.

The application of a private laboratory shall be accompanied by the following papers/documents:

a. Articles of Partnership or Incorporation of applicant;

b. Mayor's Permit of applicant;

c. Income Tax Returns duly filed and received by the Bureau of Internal Revenue for the last three (3) years;

d. Certificate of Registration of Business Name issued by the Department of Trade and Industry to the applicant;

e. Professional Regulation Commission Identification card, Tax Identification Number (TIN), Current Privilege Tax Receipt (PTR) and NBI clearance of the laboratory head';

f. One (1) 2" x 2" photograph of the laboratory head taken not less than six (6) months from the date of the application; and

g. Schematic floor plan of the laboratory indicating its size and the location of the testing equipment.

SECTION 19. Additional Supporting Documents. — An applicant shall also be required to submit the following documents:

a. Applicant for a Class B laboratory license — a certified true copy of its agreement with a licensed Class A private or government laboratory whereby the latter undertakes to conduct further confirmatory tests of specimens tested by the former, if necessary.

b. Applicant for a Class C laboratory license —

i. If the applicant is a branch, subsidiary or affiliate of a licensed Class A or Class B laboratory — a certified true copy of the license of its parent laboratory and proof that it is a branch, subsidiary or affiliate of said laboratory.

ii. If the applicant is not a branch, subsidiary or affiliate of a licensed Class A or Class B laboratory — a copy of its contract or other agreement with a licensed Class A or Class B private or government laboratory whereby the latter undertakes to conduct the confirmatory tests of positive findings made by the former after initial screening. DcSTaC

SECTION 20. Action on Application. — Upon receipt of an original application, the Board shall inspect the premises of the laboratory and evaluate the procedural aspects of the laboratory's drug testing operation.

SECTION 21. Criteria in the Grant of a License. — The Board shall consider the following criteria in determining whether or not to grant a license:

a. The adequacy of the laboratory facilities;

b. The expertise and experience of the laboratory personnel;

c. The excellence of the laboratory's quality assurance/quality control program;

d. The capability of the laboratory as disclosed in the performance test given by the Board; and

e. Other factors affecting the reliability and accuracy of the drug tests and reporting done by the laboratory.

SECTION 22. Inspection Committee. — The Board shall create a Committee in the different administrative regions to inspect the laboratory of an applicant. The Committee shall be composed of one chemist each from the National Bureau of Investigation (NBI) and the Philippine National Police (PNP) and a DIAP. The PNP and NBI members of the Committee shall be nominated by the PNP Director General and the NBI director, respectively. The DIAP shall be designated by the Executive Director. The Committee shall choose its chairman. It shall submit a written report on the results of its inspection to the Board. The report shall be signed by a majority of the members of the Committee and may include photographs of the laboratory and its facilities.

V. Fees

SECTION 23. License Fees. — Upon the filing of an application for a license, the Board shall collect the following fees from an applicant that is a private laboratory:

a. License fee

i. Class A laboratory - 5,000.00 per annum;

ii. Class B laboratory - 3,000.00 per annum; and

iii. Class C laboratory - 2,000.00 per annum.

b. Inspection fee

i. For a laboratory within Metro Manila - P500.00

ii. For a laboratory in the Luzon (outside Metro Manila) Visayas and Mindanao areas — the actual cost of transportation by the fastest means to and from the laboratory to be inspected.

VI. Issuance of License

SECTION 24. Issuance and Period of Validity of License. — The Board shall issue a license to an applicant that has complied with all the requirements established hereunder and after payment of the fees prescribed in Section 23 above. The license shall be valid for a period of one (1) year from the date of issuance.

SECTION 25. Performance Testing. — Before issuing a license, the Board shall require an applicant to successfully perform at least two (2) drug assays e.g. methamphetamine and marijuana. The applicant shall be required to have a grade of at least ninety percentum (90%) for each set/batch of samples it receives.

SECTION 26. Contests of License. — The license shall specify on its face the name of the owner or operator of the laboratory; the procedures or specialties authorized; the period for which it is valid; and the location at which said procedures shall be performed. It shall be signed by the Executive Director.

SECTION 27. Renewal of License. — The holder of a license issued under these Guidelines may file an application to renew the same within three (3) months before its expiry date, provided, that a penalty in the amount of Five Hundred Pesos (P500.00) shall be imposed on the license holder for each month it fails to file a renewal application. EHTIDA

SECTION 28. Temporary License. — An applicant may be issued a temporary license to operate laboratory if it substantially complies with minimum requirements established under these Guidelines and after payment of the corresponding fees.

SECTION 29. Display of License. — The license, as well as the professional licenses of all personnel in the laboratory, shall be displayed at all times in a conspicuous places in the laboratory where they can be viewed by the public.

SECTION 30. Listing of Licensees. — A list which contains the names of licensees according to class shall be published by the Board and shall be updated regularly.

SECTION 31. Subcontracting. — A licensee shall not subcontract its work. It shall perform all work with its own personnel and equipment unless otherwise authorized by the Board. aESICD

VII. Quality Control

SECTION 32. Laboratory Quality Control Requirements for Screening Test. — Each analytical run of specimens to be screened initially shall include:

a. Sample(s) certified to contain no drug (i.e., negative urine samples);

b. Positive control(s) fortified with drug or metabolite;

c. At least one positive control with the drug or metabolite at or near the threshold (cutoff);

d. A sufficient number of calibrators to ensure and document the linearity of the assay method over time in the concentration area of the cutoff. After acceptable values are obtained for the known calibrators, those values will be used to calculate sample data;

e. A minimum of ten percentum (10%) of the total specimens and quality control samples in each analytical run shall be quality control samples; and

f. One percentum (1%) of each run, with a minimum of at least one sample, shall be the laboratory's blind quality control samples to appear as normal samples to the laboratory analysts. Implementation of procedures to ensure that a carryover does not contaminate the testing of a donor's specimen shall be documented. aACEID

SECTION 33. Laboratory Quality Control Requirements for Confirmation Tests. — Each analytical run of specimens to be confirmed shall include:

a. Sample(s) certified to contain no drug (i.e., negative samples);

b. Positive calibrator(s) and control(s) fortified with drug or metabolite; and

c. At least one positive control with the drug or metabolite at near the threshold (cutoff). The linearity and precision of the method shall be periodically documented. Implementation of procedures to ensure that carryover does not contaminate the testing of a donor's specimen shall also be documented.

SECTION 34. Inspection of Laboratory. — The Board may direct the Inspection Committee mentioned in Section 22 hereof to conduct an on-site inspection of a licensed laboratory. The inspection shall be conducted unannounced during regular office hours. The inspection shall document the overall quality of the laboratory setting for the purposes of certification to conduct drug testing. An inspection report may recommend that a laboratory correct deficiencies noted during the inspection. The inspection report shall include photographs of the laboratory's facilities. TEacSA

VIII. Collection of Specimens

SECTION 35. Specimen Collection Standards. — A laboratory shall observe the following standards in the collection of specimens:

a. Privacy — Procedures for collecting specimens shall allow individual privacy of a donor unless there is reason to believe that a particular donor may adulterate or substitute the specimen to be provided.

b. Integrity and identity of specimen. — Licensees shall take precautions to ensure that a specimen is not substituted, altered, adulterated or diluted during the collection procedure and that the information on the container of the specimen can identify the donor thereof.

SECTION 36. Urine Specimens. — The following precautionary measures shall be observed when taking urine specimens:

a. The donor shall remove any unnecessary outer garments that might conceal items or substances that could be used to tamper with or adulterate the donor's urine specimen. All personal belongings such as a purse or briefcase shall remain with the outer garments. The donor may retain his or her wallet.

b. The donor shall be instructed to wash and dry his of her hands prior to urination.

c. After washing his hands, the donor shall remain in the presence of the collection site person and shall not have access to any water fountain, faucet, soap dispenser,cleaning agent, or any other materials which could be used to adulterate the specimen.

 

d. The collection site person shall give the donor a clean specimen bottle or specimen container. The donor may provide his/her specimen in the privacy of a lavatory, stall or partitioned area that allows for individual privacy.

e. The collection site person shall note any unusual behavior or appearance of the donor.

f. Upon receiving the specimen from the donor, the collection site person shall determine the volume of urine in the specimen bottle/container.

g. If the volume of urine is less than 60 milliliters (ml.), the test may be deferred and the donor given a reasonable period to provide said required quantity.

h. After the specimen has been provided and submitted to the collection site person, the donor shall be allowed to wash his or her hands.

i. Immediately after the specimen is collected, the collection site person shall measure only the temperature of the specimen. The temperature measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen. The time from urination to temperature measurement is critical and in no case shall exceed 4 minutes.

j. If the temperature of the specimen is outside the range of 32-38 (C/90-100 F) there is reason to believe that the donor may have altered or substituted the specimen, and another specimen shall be collected under the direct observation of a person of the same gender and both specimens shall be forwarded to the laboratory for testing. The donor may volunteer to have his or her oral temperature taken to provide evidence to counter the reason to believe the donor may have altered or substituted the specimen caused by the specimen's temperature falling outside the prescribed range. ESAHca

k. Immediately after the specimen is collected, the collection site person shall also inspect the specimen to determine its color and look for any signs of contaminants. Any unusual findings shall be noted.

l. All specimens suspected of being adulterated or diluted shall be rejected.

m. Both the donor and the collection site person shall keep the specimen bottle/container in view at all times prior to its being sealed and labeled. The seal shall be tamper-evident and may be in the form of evidence tape, a self-sealing bottle cup with both a tamper-evident seal and unique coding, cap and bottle systems that can only be sealed one time, or any other system that ensures any tampering with the specimen will be evident to laboratory personnel during the accessioning process.

n. The collection site person and the donor shall be present at the same time during procedures outlined in paragraphs q. to s. of this Section.

o. The collection site person shall place securely on the specimen bottle an identification label which contains the date and the donor's specimen number.

p. The donor shall initial the identification label on the specimen bottle for the purpose of certifying that it is the specimen collected from him or her.

q. The collection site person shall note all information identifying the specimen.

r. The donor shall be asked to read and sign a statement certifying that the specimen identified as having been collected from him or her is in fact that specimen he or she provided.

s. To the maximum extent possible, the collection site personnel shall keep the donor's urine specimen bottle within sight both before and after the donor has urinated. After the specimen is collected, each time the same is handled or transferred shall be noted and every individual handling the same shall be identified. Every effort shall be made to minimize the number of persons handling specimens. TICAcD

IX. Laboratory Report

SECTION 37. Form of Screening Test Result. — The test result of a licensed laboratory shall be in the form prescribed by the Board and shall be accomplished in triplicate.

SECTION 38. Signatory of Test Result. — The result of the confirmatory/quantitative/screening test made by Class A and B licensed laboratories shall be signed by the chemist who conducted the test. The result of the screening test of a Class C laboratory shall be signed by the chemist, medical technologist or pharmacist who actually conducted the test. All test reports shall be duly noted by the head of the laboratory.

SECTION 39. Distribution of Test Result Form. — The original copy of the test result form shall be given to the donor immediately upon its completion. One copy each of said test result form shall be furnished the Board and the agency that requires the test not later than one (1) month from the date the test result from is issued to the donor. The test results that are forwarded to the Board shall be accompanied with the membrane of the validated drug testing kit in the case of screening tests and with a copy of the chromatogram in the case of confirmatory and quantitative tests.

SECTION 40. Period of Validity of Screening Test Result. — A screening test result shall be valid for fifteen (15) days from the date of examination.

SECTION 41. Access to Laboratory Test Results. — The drug test report and the records of a licensee shall be confidential. The same may only be revealed upon written consent of the donor, or if the donor is a minor, of his patient or legal guardian.

X. Proficiency Testing

SECTION 42. Proficiency Testing. — The Board shall conduct a continuing assessment of the proficiency of Class A and B licenses. A licensee shall be challenged with at least five (5) proficiency testing samples in one year. All procedures associated with the handling and testing of the proficiency testing sample shall to the greatest extent possible, be carried out in a manner identical to that applied to routine specimens, unless otherwise specified. CTaIHE

SECTION 43. Participation in Proficiency Test. — The failure of a Class A or B licensee to participate satisfactorily in the proficiency testing conducted by the Board may result in the suspension or revocation of its license.

SECTION 44. Results of Proficiency Test. — The results of a proficiency test of a Class A or B licensee shall be submitted to the Board within three (3) weeks after receipt of the test samples. Said results shall be confidential.

SECTION 45. Failure to Pass Proficiency Test. — A Class A or B licensee that fails to pass the proficiency test conducted by the Board shall be given another test not earlier than one (1) month after the failed test. Failure to pass the second proficiency test shall result in the suspension of its license for a period of six (6) months or the revocation thereof.

XI. Suspension or Revocation of License

SECTION 46. Suspension or Revocation of License. — The Board may, motu proprio and after hearing, suspend or revoke a license for such period and under such terms as may be necessary to ensure the full reliability and accuracy of drug test and the accurate reporting of test results. Provided, that the Board may immediately suspend a license whenever there is a reason to believe that the same is necessary to protect the interest of the Government and the public.

SECTION 47. Factors to Consider. — The Board shall consider the following factors in determining whether the suspension or revocation of a license is necessary:

a. unsatisfactory performance in analyzing and reporting the results of drug tests such as false positive error in reporting the result of a drug test; DACTSa

b. failure of a Class A or B licensee to participate in a proficiency test or unsatisfactory laboratory inspection;

c. a material violation of any of the terms and conditions established in the license or in these Guidelines;

d. conviction of the owner or manager of a laboratory for any criminal offense committed as an incident to the operation of the laboratory;

e. failure to furnish the Board with copies of test results forms as required in Section 39 hereof; or

f. any other cause which materially affects the ability of the laboratory to ensure the full reliability and accuracy of drug tests and the accurate reporting of results.

SECTION 48. Reapplication for License. — A laboratory whose license has been revoked may reapply for the issuance of a new one upon compliance with the requirements established hereunder and/or the correction of the deficiency which resulted in the revocation.

XII. Final Provisions

SECTION 49. Injunction. — Six (6) months after these Guidelines take effect, only laboratories that are granted a license pursuant thereto shall be allowed to perform drug tests and the Board may, in addition to other legal remedies, bring an action for an injunction to restrain or enjoin the future operation or maintenance of an unlicensed laboratory. Provided, that a laboratory that has been issued a license by the Board before the issuance of these Guidelines shall be allowed to continue to operate for a period of three (3) months after the approval of these Guidelines, Provided Further, that said laboratory shall file an application for a new license hereunder on or before the end of said period. Otherwise, existing license of said laboratory shall be deemed revoked.

SECTION 50. Violations. — Any violation of these Guidelines shall subject the president, partner, director, manager, officer, stockholder, or employee of a laboratory to administrative and/or criminal sanctions, as may be warranted in the premises.

SECTION 51. Repealing Clause. — All regulations, rules or other issuance of the Board which are contrary to or inconsistent herewith are repealed accordingly. DTaSIc

XIII. Effectivity

SECTION 52. Effectivity. — These Guidelines shall take effect fifteen (15) days after its publication in a newspaper of general circulation.

DONE in the City of Manila, this ____ day of ______, 2000.

(SGD.) ARTEMIO G. TUQUEROSecretary of Justice and

(SGD.) ALBERTO G. ROMUALDEZ, JR.Secretary of Health

(SGD.) DULCE Q. SAGUISAGSecretary of Social Welfare and Development

(SGD.) ORLANDO S. MERCADOSecretary of National Defense

 

(SGD.) ANDREW B. GONZALEZ, FSCSecretary of Education, Culture and Sports

ATTESTED:

(SGD.) REY M. SAN PEDRO, M.D.Executive Director and Board Member