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Module 16: Board Regulation No. 1, S. 2000 Page 1 of 1 0

Topic: BOARD REGULATION NO. 1, S. 2000

W E L C O M E C R IM IN O L O G Y S T U D E N T S

I. IN T R O D U C T IO N :

“Drugs are enemies of ambition and hope and when we fight against drugs we are
for the future”
- Bob Riley
II. O B J E C T IV E S :

At the end of this lesson, you should be able to:

1. Identify the different terms use in the board regulation no.1 S.2000
2. Determine the categories of laboratories
3. Discuss the application for license

III. P R E L IM IN A R Y A C T IV IT IE S :

Before you proceed to the main lesson, read the summary of the video.
Source:

Direction/Instruction: Arranged the jumbled letters.

1. T F L C A I Y I - __________________________________________________________
Hint: A place, amenity, or piece of equipment provided for a particular purpose.

2. N T Q P M E E I U - ______________________________________________________
Hint: The process of supplying someone or something with items necessary for a particular
purpose.

GREAT!!!
You may now proceed to the main lesson.
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Module 16: Board Regulation No. 1, S. 2000 Page 2 of 1 0

IV . L E S S O N P R O P E R

Based on the preliminary activities, what did you notice about it?
________________________________________________________
CONGRATULATIONS!
You may now proceed to the lesson.

BOARD REGULATION NO. 1, S. 2000

SUBJECT: LICENSING OF DANGEROUS DRUGS
TESTING LABORATORIES AND PRESCRIBING THE STANDARDS FOR THEIR OPERATION

A) GENERAL PROVISIONS

SEC. 1. Definition of Terms

Specimen: Refers-to the body fluid that is collected from a person;
Laboratory: Refers to the private or government agency that is capable of testing a specimen to determine
the presence of dangerous drugs therein;
License: Refers to the authority granted by the Board to operate and maintain a laboratory;
Donor: Refers to the individual from whom a specimen is collected;
Applicant: Refers to that laboratory that is applying for the issuance of a license;
License: Refers to the laboratory that is issued a license;
Chairman: Refers to the Chairman of the Board;
Executive Director: Refers to the Executive Director of the Board;
Drug identification Analysis or "DIAP": Refers to a licensed-medical. technologist, pharmacist or
chemical or engineer who has undergone intensive training on the conduct of laboratory examination/tests
to identify dangerous drugs on a specimen.
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
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Confirmatory Test: refers to the. Second or further analytical procedure to identify the presence of drugs
in a specimen.

CATEGORIES OF LABORATORIES

SEC: 2. Categories of Laboratories - There shall be three categories of drugs testing laboratories, to wit:
a. Class A-This laboratory shall be capable of conducting screening and confirmatory tests and the
quantitative examination of specimen.
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.
SEC. 3. Laboratory Equipment. - A laboratory shall be required to have the following equipment:
a. Class A This shall have the following instruments:
1. For screening tests - immunoassay Equipment and Validated Drug Testing Kit.
2. For Confirmatory Tests - thin Layer Chromatograph.
3. For Quantitative Examination - Mass-Spectrometer-Gas Chromatograph (GS-MS) and High
Performance Liquid Chromatograph (HPLC)
4. Basic Equipment- Laboratory. Oven, Sample Concentrator Centrifuge, Water Bath, Weighing Scale,
Shaker, Refrigerator, Freezer
b. Class B
1. For Screening Tests-: Immunoassay and Validated Drug Testing Kit.
2. For confirmatory tests - Thin Layer Chromatography.
3. Basic Equipment - same as Class A Laboratory
C. Class C - For Screening Test- Immunoassay equipment and/or Validated Drug Testing Kit.
SEC. 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 square meters with instrumentation room, work(left)
area, storage cabinet and wash room
b. Class B - This shall have at least forty square meters with a work (wet) area, storage cabinet and
wash room; and
c. Class C - This shall have at least twenty square meters with a work area, exhaust fan, lavatory,
storage cabinet and wash room.
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SEC. 5. Receiving Area - A laboratory whatever Class shall have within "its premises an area, which. can
receive or accommodate at least twenty prospective donors at a given time, and a lavatory, stall or other
partitioned area for the orderly collection of specimens.
SEC. 6. Staff of laboratories- A laboratory shall have the following technical staff who may also be its
heads:
a. Class A This shall have a licensed-chemist and medical technologist or 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 how has
successfully completed training in chromatography;
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 a laboratory test.

SEC. 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 proficiency test to be established by the Board.
specimen in their possession and shall complete-chain of custody forms therefor.
SEC. 12. Storage of Records and Specimens.-. all records pertaining to specimens shall be kept by the
testing laboratory for a minimum of period of two years. The specimens in positive test results, which are
not challenged within fifteen days upon receipt by the donor of, said results should be discarded.
SEC. 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.
SEC. 14. Procedure Manual laboratory - shall have a procedure manual which shall include the principles
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 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.
SEC. 15. Calibrators and Controls. - laboratory calibrators and controls shall be prepared using pure drug
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reference materials, stock standard solutions obtained from other laboratories, or standard solutions
obtained from commercial manufactures. The calibrators and controls shall be labelled as to content and
concentration. The standards shall be labelled with the following data: when received, when prepared or
opened; when placed in service; and expiration date, If a laboratory uses testing its, the test reagents shall
be validated and licensed by the Board and registered with the Bureau of Food and Drugs.

SEC. 16. Instruments and Equipment - Volumetric pipettes and measuring devices shall be certified for
accuracy or be checked by gravimetric, or other verification procure. 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 instruments set-up and normal 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.

D) APPLICATION FOR LICENSE

SEC. 17. Application, Where to File. - An applicant for a license shall be filed with the office of the
Executive Director.
SEC. 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.

We had just finished the discussion on the Educational Approach.

Let’s move on to the next higher level of activity/ies or exercise/s that
demonstrate your potential skills/knowledge of what you have learned.
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V . A N A L Y S IS , A P P L IC A T IO N A N D E X P L O R A T IO N
ACTIVITY 1
Name: ______________________________ Course & Section: __________________
Direction: Read carefully each question and write your answer on the space provided.

L ab o rato ry L icen se E xecu tive D irecto r

C o n firm ato ry test Donor

_________________1. Refers to that facility that is applying for the issuance of a license.

_________________2. Refers to the authority granted by the Board to operate and maintain a laboratory.

_________________3. Refers to the Second or further analytical procedure to identify the presence of
drugs in a specimen.
_________________4. Refers to the individual from whom a specimen is collected

_________________5. Refers to the Executive Director of the Board

ACTIVITY 2

Direction: Identify what category of laboratories are being asked. Write your answer on the space provided.

CLASS A CLASS B CLASS C

_________________ This shall be capable of performing Screening and confirmatory tests.

_________________2. This category of laboratory should have Mass-Spectrometer-Gas Chromatograph

(GS-MS) and High Performance Liquid Chromatograph (HPLC)
_________________3. This laboratory shall only be capable of conducting screening tests.

_________________4. This laboratory shall have at least twenty square meters with a work area, exhaust
fan, lavatory, storage cabinet and wash room.
________________ 5. This category of laboratory shall have a licensed. chemist, medical
technologist/pharmacist or one how has successfully completed training in
chromatography
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Finally, let us summarize the lesson of what we had

discussed today.

V I. G E N E R A L IZ A T IO N
Direction/Instruction: Read the question carefully and answer in not less than 3 sentences. Rubric
is attached for reference and guidance.
1. Discuss the application for license
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________

Rubric:
Level Description Score
 Well written and very organized.
 Excellent grammar mechanics.
OUTSTANDING  Clear and concise statements. 9-10
 Excellent effort and presentation with detail.
 Demonstrates a thorough understanding of the topic.
 Writes fairly clear.
 Good grammar mechanics.
GOOD 7-8
 Good presentation and organization.
 Sufficient effort and detail
 Minimal effort.
 Good grammar mechanics.
FAIR 6
 Fair presentation.
 Few supporting details.
 Somewhat unclear.
 Shows little effort.
POOR  Poor grammar mechanics. 5
 Confusing and choppy, incomplete sentences.
 No organization of thoughts.
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KUDOS!
You have come to an end of Module 16.
O O P S ! Don’t forget that you have still an assignment to do.
Here it is….

V II. A S S IG N M E N T

Name: ___________________________________ Course & Section: __________________

Direction: Fill in the blanks, choose the correct answer and write it on the space provided below.

BUREAU OF FOOD AND DRUGS COMMERCIAL CALIBRATORS

EXPIRATION TEST REAGENTS

Laboratory ________________ and controls shall be prepared using pure drug reference materials, stock
standard solutions obtained from other laboratories, or standard solutions obtained from
__________________ manufactures. The calibrators and controls shall be labelled as to content and
concentration. The standards shall be labelled with the following data: when received, when prepared or
opened; when placed in service; and __________________ date, If a laboratory uses testing its, the
______________________ shall be validated and licensed by the Board and registered with the
_______________________________.

(This assignment will be submitted on ________________.)

After your long journey of reading and accomplishing

the module, let us now challenge your mind by
answering the evaluation part of this module.
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V III. E V A L U A T IO N

Name:___________________________________ Course & Section: __________________

Direction/Instruction: Read carefully each question and encircle the letter of the correct answer.

1. It refers-to the body fluid that is collected from a person.

A. Specimen
B. Donor
C. Confirmatory test
D. Drug identification Analysis or "DIAP"
2. This shall have a licensed medical technologist/pharmacist or a chemical engineer.
A. Class A
B. Class B
C. Class C
D. No correct Answer
3. These laboratories shall have qualified personnel who can testify in any administrative, criminal or
other proceeding on the results of a laboratory test.
A. Class A and C
B. Class A and B
C. Class B and C
D. All answers are correct
4. A laboratory whatever Class shall have within "its premises an area, which. can receive or
accommodate at least twenty prospective donors at a given time.
A. Staff of laboratories
B. Storage of records
C. Lounge
D. Receiving Area
5. Refers to a licensed-medical. technologist, pharmacist or chemical or engineer who has undergone
intensive training on the conduct of laboratory examination/tests to identify dangerous drugs on a
specimen.
A. Specimen
B. Donor
C. Confirmatory test
D. Drug identification Analysis or "DIAP"
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6. The specimens in positive test results, which are not challenged upon receipt by the donor of, said
results should be discarded in how many days?
A. 13 days C. 15 days
B. 14 days D. 1 month
7. The Class A laboratory shall be required to have the following equipment except _____?
C. For Quantitative Examination
A. For screening tests
D. Basic Equipment
B. For Confirmatory Tests
8. What class of Laboratory facility shall have at least forty square meters with a work (wet) area,
storage cabinet and wash room?
A. Class A C. Class C
B. Class B D. All answers are correct
9. This class of laboratory facility requires to have at least twenty square meters with a work area,
exhaust fan, lavatory, storage cabinet and wash room.
A. Class A C. Class C
B. Class B D. All answers are correct
10. This laboratory facility has at least one hundred square meters with instrumentation room, work(left)
area, storage cabinet and wash room
A. Class A C. Class C
B. Class B D. All answers are correct

(This evaluation will be submitted on ________________.)

C O N G R A T U L A T IO N S on reaching the end of this module!

You may now proceed to the next module.
Don’t forget to submit all the exercises, activities and portfolio
on ___________________.
KEEP UP THE GOOD W ORK.
Well Done!!!