[ LTO MEMORANDUM CIRCULAR NO. BGC-MC-99278, May 14, 1999 ]
IMPLEMENTING GUIDELINES OF ADMINISTRATIVE ORDER NO. BGC-AO-001 RE RULES AND REGULATIONS IN THE IMPLEMENTATION OF THE DRUG TESTING OF PROFESSIONAL DRIVER'S LICENSE HOLDERS/APPLICANTS
SECTION 1. Introduction. - In consonance to the directive of the President to ensure road safety in the Philippines and pursuant to AO No. BGC-AO-001 and Republic Act No. 4136, section 22 as amended by Batas Pambansa Blg. 398 which states that, "every person who desires to operate any motor vehicle shall file an application to the Director or his deputies for a license to drive motor vehicles: Provided however, that no person shall be issued a professional driver license who is suffering from contagious diseases such as tubercolosis, sexually transmitted disease and epilepsy or who is an alcohol or drug addict or dependent" the following rules and regulations shall be observed:
SECTION II. Definition of Terms. -
a. Drug - a Methamphetamine (shabu), Cannabinoids (marijuana).
b. Drug-test - Any chemical, biological or physical instrument analusis administered by a laboratory for the purpose of determining the presence or absence of a drug or its metabolite.
c. Methamphetamine (Shabu) - are synthetic amphetamines or stimulant that are produced and sold illegally in pill form, capsules, powder or chunks. Two such methamphetamine are chunks and ice.
d. Cannabinoids (Marijuana) - hemp like plant whose leaves are smoked in cigarettes as a narcotic.
e. LTO - Land Transportation Office
f. NCR - National Capital Region
g. Application fee - shall mean the amount to be collected upon filing an application for accreditation.
h. Accreditation Permit - shall mean the authority granted by the Dangerous Drugs Board (DDB) and Land Transportation Office (LTO) to be able to transact business relative to drug testing.
i. DDB - Dangerous Drug Board
j. Chain of Custody - refers to the procedure established by the testing laboratory for the handling of specimens. It ensures that sample identification and integrity are maintained. it also accounts for the integrity of each specimen by tracking its handling and storage from specimen collection to final disposition of the specimen.
SECTION III. Accreditation of Drug Laboratories. -
A. Drug-testing Laboratory
LTO shall adopt the laboratory classification of the DDB such as:
1. CLASS A LABORATORIES - are those that are capable of performing with competence, qualitative and quantitative examinations of dangerous drugs in the body fluids.
This class of laboratory must have all the analytical instruments, equipment, glasswares, material and reagents that are necessary for the qualitative and quantitative examinations of dangerous drugs in the body fluids.
2. CLASS B LABORATORIES - are those that are capable of performing with competence, qualitative and quantitative examinations of dangerous drugs in the body fluids, using sophisticated equipment other than the GC-MS, such as Immunoassay equipment or its equivalent, UV Spectrometer, TLC or HPTLC, GC and HPLC.
3. CLASS C LABORATORIES - are those which are capable of performing with competence, qualitative examinations of dangerous drugs in the body fluids. The laboratories shall collaborate with a Class A or B laboratory for the confirmation of their positive findings in the body fluids, if necessary. This class of laboratory shall have the necessary instruments, equipment, glasswares, reagents and materials for the analysis and identification of dangerous drugs in the body fluids.
4. CLASS D LABORATORIES - are those that are capable of performing with competence, preliminary examination of dangerous drugs in the body fluids. Class D laboratories shall collaborate with class A or B laboratories for confirmations of their positive results. This class of laboratory must have any of the following testing equipment to undertake the analysis, such as EMIT, RIA, FPIA and Validated Drug Testing Kit.
B. Procedure
In applying for accreditation of laboratory for drug tests, the following steps shall be followed:
Upon filing of the application for accreditation, an application fee shall be collected hereinafter set forth.
In case of the National Capital Region (NCR), application shall be filled at the LTO Central Office, East Ave., Quezon City; while in case of other regions of the country, application shall be filed at the LTO Regional Office where the concerned laboratory operates. In order to update the database of all accredited laboratories in the country, a list of the approved applications shall be submitted to the Medical Unit, Central Office, East Avenue, Quezon City for monitoring.
B.3
Upon approval of the application, an accreditation fee shall be collected hereinafter set forth.
C. Renewal of Accreditation:
The renewal of accreditation shall be filed, processed and approved at the LTO Regional Office where the laboratory operates. However, in case of NCR, it shall be done at the LTO Central Office. Likewise, the Medical Unit, LTO Central Office, will ask from DDB a list of updated accredited laboratories.
SECTION IV. Documentary Requirements. - The following documents shall be submitted upon filing an application for accreditation/authorization:
a. Certificate of Accreditation of the laboratory from DDB, duly signed by the Chairman of the Board for classes A and B laboratories and by the Executive Director of the Board and Chairman of the Accreditation Committee for classes C & D;
b. Certification from the Dangerous Drugs Board (DDB) authorizing the laboratory director/physician to conduct drug testing;
c. Certificate of Dangerous Drugs Board certified physician;
d. A license of the laboratory director from the Professional Regulation Commission as a medical doctor or doctor of osteopathy;
e. Certificate of training of the licensed Medical Technologist provided by the company supplying the said machine;
f. Samples of chain of custody forms and procedure;
g. Certificate of Business Name Registration from the Department of Trade and Industry (DTI), if single proprietorship;
h. Securities and Exchange Commission (SEC) Certificate of Registration and Articles of Incorporation and By-laws, if corporation and partnership;
i. Valid and appropriate mayor's permit;
j. Tax identification number (TIN) from the Bureau of Internal Revenue (BIR) in case business has been operating for less than one year.
k. Latest Income Tax Return;
l. Certificate of Business membership with Social Security System (SSS);
m. Specimen signatures of accredited physicians, Medical Technologists who are authorized to sign the certificates.
SECTION V. Technical Requirements. - The drug testing laboratories should meet the requirements of the DDB for accreditation. In addition to the requirements of DDB, LTO shall require the following:
- Specimen signatures of the authorized certificate signatories;
- Certificates made of security paper with security markings to prevent faking certificates.
SECTION VI. Reporting System. - All accredited laboratory physicians shall make a periodic report on the results of the drug tests that was conducted, to the Central Office or LTO Regional Offices as the case maybe. For drug test, it shall be identified on the report, the drug that was tested for, Methamphetamine or Cannabinoids and whether positive or negative. The test results shall be treated confidential.
SECTION VII. Interpretation of Results. -
1. Results will be printed individually or altogether in one official form with seal.
2. Those who turned out to be positive, their sample shall be sent to PNP Crime Laboratory or DDB for confirmation. The subject sample should be submitted within 15 days after collection.
3. As confirmed by the PNP Crime Laboratory or the DDB, the DDB accredited physician for appropriate management will subject the positive individuals to clinical evaluation.
SECTION VIII. Fees. - The amount to be collected for the accreditation fee, penalty for late renewal and administrative fine for offenses shall be covered by the Department Order on the Increase of Fees and Charges.
SECTION IX. Validity. - The Accreditation Permit shall be valid for one (1) year reckoned from the date of approval thereof, renewable annually thereafter.
SECTION X. Penal Provisions. - The accredited laboratory director/physician shall be penalize with an administrative fine for the first offense, one (1) year suspension for the second offense, and cancellation of the Accreditation Permit for the third offense for the following violations:
a. Submission of anomalous report as required by law and regulations;
b. Non-compliance with the standard requirements herein provided and other laws and its implementing rules and regulations;
c. Misrepresentation in the filing of the application and/or in its operation.
Any person, firm, partnership or corporation found operating as an accredited laboratory of the LTO on drug tests without an Accreditation Permit, or without having filed an application for accreditation, shall be penalized and/or denied transaction with the LTO.
All previous orders/memoranda and other issuances in conflict herewith are deemed superseded.
For guidance and strict compliance.
Adopted: 14 May 1999
(SGD.) ATTY. BENJAMIN G. CALIMA
Assistant Secretary
SECTION II. Definition of Terms. -
a. Drug - a Methamphetamine (shabu), Cannabinoids (marijuana).
b. Drug-test - Any chemical, biological or physical instrument analusis administered by a laboratory for the purpose of determining the presence or absence of a drug or its metabolite.
c. Methamphetamine (Shabu) - are synthetic amphetamines or stimulant that are produced and sold illegally in pill form, capsules, powder or chunks. Two such methamphetamine are chunks and ice.
d. Cannabinoids (Marijuana) - hemp like plant whose leaves are smoked in cigarettes as a narcotic.
e. LTO - Land Transportation Office
f. NCR - National Capital Region
g. Application fee - shall mean the amount to be collected upon filing an application for accreditation.
h. Accreditation Permit - shall mean the authority granted by the Dangerous Drugs Board (DDB) and Land Transportation Office (LTO) to be able to transact business relative to drug testing.
i. DDB - Dangerous Drug Board
j. Chain of Custody - refers to the procedure established by the testing laboratory for the handling of specimens. It ensures that sample identification and integrity are maintained. it also accounts for the integrity of each specimen by tracking its handling and storage from specimen collection to final disposition of the specimen.
SECTION III. Accreditation of Drug Laboratories. -
A. Drug-testing Laboratory
LTO shall adopt the laboratory classification of the DDB such as:
1. CLASS A LABORATORIES - are those that are capable of performing with competence, qualitative and quantitative examinations of dangerous drugs in the body fluids.
This class of laboratory must have all the analytical instruments, equipment, glasswares, material and reagents that are necessary for the qualitative and quantitative examinations of dangerous drugs in the body fluids.
2. CLASS B LABORATORIES - are those that are capable of performing with competence, qualitative and quantitative examinations of dangerous drugs in the body fluids, using sophisticated equipment other than the GC-MS, such as Immunoassay equipment or its equivalent, UV Spectrometer, TLC or HPTLC, GC and HPLC.
3. CLASS C LABORATORIES - are those which are capable of performing with competence, qualitative examinations of dangerous drugs in the body fluids. The laboratories shall collaborate with a Class A or B laboratory for the confirmation of their positive findings in the body fluids, if necessary. This class of laboratory shall have the necessary instruments, equipment, glasswares, reagents and materials for the analysis and identification of dangerous drugs in the body fluids.
4. CLASS D LABORATORIES - are those that are capable of performing with competence, preliminary examination of dangerous drugs in the body fluids. Class D laboratories shall collaborate with class A or B laboratories for confirmations of their positive results. This class of laboratory must have any of the following testing equipment to undertake the analysis, such as EMIT, RIA, FPIA and Validated Drug Testing Kit.
B. Procedure
In applying for accreditation of laboratory for drug tests, the following steps shall be followed:
B.1 | The applicant shall submit a duly accomplished application form, together with the documentary requirements hereinafter set forth, to the LTO through the Committee on Accreditation. |
Upon filing of the application for accreditation, an application fee shall be collected hereinafter set forth.
In case of the National Capital Region (NCR), application shall be filled at the LTO Central Office, East Ave., Quezon City; while in case of other regions of the country, application shall be filed at the LTO Regional Office where the concerned laboratory operates. In order to update the database of all accredited laboratories in the country, a list of the approved applications shall be submitted to the Medical Unit, Central Office, East Avenue, Quezon City for monitoring.
B.2 | The Committee on Accreditation shall be created with the following duties and responsibilities: |
1. Evaluates the applications, conducts ocular inspection of the laboratory, facilities and equipment and recommends approval or disapproval of application to the LTO Assistant Secretary depending upon the result of evaluation.
2. See to it that the drug testing laboratories operate at all times in accordance with the terms and conditions of their registration and accreditation.
3. Provide proper interpretation of the given and specific requirements that shall govern the operations of the laboratory.
4. See to it that the technical demands involved in laboratory work are met.
5. Conduct surprise/periodic inspection of the accredited laboratory to ensure its effectiveness.
6. Perform such other duties as may be assigned to it.
The Assistant Secretary - upon finding the application satisfactory, may approve the application and issue an accreditation permit.
Upon approval of the application, an accreditation fee shall be collected hereinafter set forth.
C. Renewal of Accreditation:
The renewal of accreditation shall be filed, processed and approved at the LTO Regional Office where the laboratory operates. However, in case of NCR, it shall be done at the LTO Central Office. Likewise, the Medical Unit, LTO Central Office, will ask from DDB a list of updated accredited laboratories.
C.1 | The applicant shall present its latest Accreditation Permit and the corresponding official receipt of payment to the LTO Regional office or LTO Central Office as the case may be. |
C.2 | In securing the renewed accreditation permit, the accredited laboratory must submit a valid and appropriate mayor's permit. |
SECTION IV. Documentary Requirements. - The following documents shall be submitted upon filing an application for accreditation/authorization:
a. Certificate of Accreditation of the laboratory from DDB, duly signed by the Chairman of the Board for classes A and B laboratories and by the Executive Director of the Board and Chairman of the Accreditation Committee for classes C & D;
b. Certification from the Dangerous Drugs Board (DDB) authorizing the laboratory director/physician to conduct drug testing;
c. Certificate of Dangerous Drugs Board certified physician;
d. A license of the laboratory director from the Professional Regulation Commission as a medical doctor or doctor of osteopathy;
e. Certificate of training of the licensed Medical Technologist provided by the company supplying the said machine;
f. Samples of chain of custody forms and procedure;
g. Certificate of Business Name Registration from the Department of Trade and Industry (DTI), if single proprietorship;
h. Securities and Exchange Commission (SEC) Certificate of Registration and Articles of Incorporation and By-laws, if corporation and partnership;
i. Valid and appropriate mayor's permit;
j. Tax identification number (TIN) from the Bureau of Internal Revenue (BIR) in case business has been operating for less than one year.
k. Latest Income Tax Return;
l. Certificate of Business membership with Social Security System (SSS);
m. Specimen signatures of accredited physicians, Medical Technologists who are authorized to sign the certificates.
SECTION V. Technical Requirements. - The drug testing laboratories should meet the requirements of the DDB for accreditation. In addition to the requirements of DDB, LTO shall require the following:
- Specimen signatures of the authorized certificate signatories;
- Certificates made of security paper with security markings to prevent faking certificates.
SECTION VI. Reporting System. - All accredited laboratory physicians shall make a periodic report on the results of the drug tests that was conducted, to the Central Office or LTO Regional Offices as the case maybe. For drug test, it shall be identified on the report, the drug that was tested for, Methamphetamine or Cannabinoids and whether positive or negative. The test results shall be treated confidential.
SECTION VII. Interpretation of Results. -
1. Results will be printed individually or altogether in one official form with seal.
2. Those who turned out to be positive, their sample shall be sent to PNP Crime Laboratory or DDB for confirmation. The subject sample should be submitted within 15 days after collection.
3. As confirmed by the PNP Crime Laboratory or the DDB, the DDB accredited physician for appropriate management will subject the positive individuals to clinical evaluation.
SECTION VIII. Fees. - The amount to be collected for the accreditation fee, penalty for late renewal and administrative fine for offenses shall be covered by the Department Order on the Increase of Fees and Charges.
SECTION IX. Validity. - The Accreditation Permit shall be valid for one (1) year reckoned from the date of approval thereof, renewable annually thereafter.
SECTION X. Penal Provisions. - The accredited laboratory director/physician shall be penalize with an administrative fine for the first offense, one (1) year suspension for the second offense, and cancellation of the Accreditation Permit for the third offense for the following violations:
a. Submission of anomalous report as required by law and regulations;
b. Non-compliance with the standard requirements herein provided and other laws and its implementing rules and regulations;
c. Misrepresentation in the filing of the application and/or in its operation.
Any person, firm, partnership or corporation found operating as an accredited laboratory of the LTO on drug tests without an Accreditation Permit, or without having filed an application for accreditation, shall be penalized and/or denied transaction with the LTO.
All previous orders/memoranda and other issuances in conflict herewith are deemed superseded.
For guidance and strict compliance.
Adopted: 14 May 1999
Assistant Secretary