MT6313 RA9165 Flashcards
What is the title of RA9165?
Comprehensive Dangerous Drugs Act of 2002
When was 9165 approved?
June 7, 2002
What does 9165 repeal?
Repealing RA 6425, otherwise known as the Dangerous Drugs Act of 1972 (March 30, 1972)
What act amends 9165? and when was it signed?
RA 10640 (JUL 15 2014)
What is the declaration of policy of 9165?
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
- to defend the same against acts or omissions detrimental to their development and preservation.
What is an act of introducing any dangerous drug into the body of any person, with or without his/her knowledge?
Administer
Illegal administration is through what ways?
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
When is administration of a dangerous drug permissible?
When it is administered by a duly licensed practitioner for purposes of medication.
Who is a professional who perform the drug testing?
Analyst
Who can be an analyst?
Medical Technologist
Chemist
Chemical Engineer
Pharmacist
Which of the following analysts need additional training and certification?
MT and clinical lab scientists
person who is authorized to collect specimen from the client to secure and prevent alteration of Urine specimen.
Authorized Specimen Collector
What form indicates the people who handles the specimen with a specific time and date?
Chain of custody form
facility used for the illegal manufacture of any dangerous drug and/or controlled precursor and essential chemical
Clandestine Laboratory
procedure to account for each specimen by tracking the handling and storage from point of collection to final disposal
Chain of Custody
Chain of custody procedure requires that the _____ is confirmed and that a _______ that is used from the time of collection to receipt by the laboratory.
applicant’s identity; chain of custody form
form used to document the procedures from the time of
collection until receipt by the laboratory.
Chain of Custody Form
What are the most commonly tested dangerous drugs?
Methamphetamine (Shabu)
Tetrahydrocanabinol (Marijuana)
What are the other parameters that are tested?
Ecstacy
Opium
Cocaine
Who is the DDB Chairman?
Catalino Cuy
What is the implementer force that arrests those who use dangerous drugs or who violate RA9165?
PDEA (Philippine Drug Enforcement Agency)
Who is the head of PDEA?
Moro Virgilio M. Lazo
What is the NRL for environmental and occupational health, toxicology and micronutrient assay?
EAMC (East Avenue Medical Center)
rapid test performed to establish potential/presumptive
positive result.
Screening Test
Is Screening test quantitative or qualitative?
Qualitative
Is a person (+) when the screening is positive ONLY?
No, need confirmatory test to be (+) as well to be really positive for the DD
Is the person (+) or (-) if the screening test is positive and the confirmatory is (-)?
No, s/he is (-) and the screening test is disregarded
What defines a confirmatory test?
analytical test using a device, tool or equipment with a different chemical or physical principle that is more specific which will validate and confirm the result of the screening test
body fluid that is collected from a person
Specimen
What is the most common specimen for drug testing?
Urine
What does challenge mean?
The client can ask to repeat the test; where a drug is given slowly in gradually increasing amounts to diagnose or rule out a true drug allergy.
Drug Testing Labs based on ownership?
Government
Private
Drug Testing Labs based on institutional character?
Institutional Based
Freestanding
Drug Testing Labs based on service capability?
Screening Laboratory
Confirmatory Laboratory
Which individuals are required for mandatory drug testing?
- Applicants for Firearms License
- Officers and members of the military, police and other law enforcements
- Candidates for Public Office
- Persons charged before the prosecutor’s office with criminal charge offense having an impossible penalty of imprisonment of not less than 6years and 1day
- Persons apprehended for the violations of this act
Who are subject to random drug testing?
Students of Secondary or Tertiary schools
Officers and employee of public and private and private offices whether domestic or overseas.
What are the physical plant technical requirements for licensing in a 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.
What are the physical plant technical requirements for licensing in a 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 how many clients at a time?
5 client at a time.
What facilities must be present for the collection of specimen?
With a hand washing facility, Toilet facility, and a stall for the collection of the specimen
What is required for the headship of the laboratory?
A licensed Physician certified in Clinical Pathology by the Philippine Board of Pathology
If not available, a licensed physician with training in Clinical Laboratory Management.
In case when a Laboratory is a division of the Laboratory, Licensed Physician, Chemist, Medical Technologist, Pharmacist or a Chemical Engineer.
A licensed Chemist with at least Master’s Degree in Chemistry, Biochemistry or branch of chemistry with at least 2years experience in analytical chemistry.
What are requirements for personnel in a screening laboratory?
full time Medical Technologist, Chemist, Pharmacist, and Chemical Engineer with appropriate training in screening procedures for dangerous drugs
What are requirements for personnel in a confirmatory laboratory?
full time Medical Technologist, Chemist, Pharmacist and Chemical Engineer who has completed an extensive appropriate training in chromatography, spectroscopy.
The analyst must pass the proficiency test (given by NRL)
What are the requirements for the lab equipment in a screening lab?
necessary equipment or kit.
What are the requirements for the lab equipment in a confirmatory lab?
necessary equipment for screening, qualitative and quantitative examination in addition to the basic equipment.
Requirements for the application service provider?
Laboratory shall have access to an Application Service Provider approved by the DOH for the authentication of results.
What is an application service provider?
Laboratory information system for clients to have access to their drug analysis
How long are the drug tests good for?
1yr
What are the roles of DOH in the accreditation of drug testing centers and physicians?
License and accredit drug testing centers
Appoint technical and other personnel for effective implementation of this law
Accredit physicians who shall conduct the drug dependency exam and after care
Control of regulations, licensing and accreditation division
Establish, operate and maintain drug testing canters in government hospitals (At least basic technologically advanced equipment and materials)
Appoint qualified and duly trained technical and other personnel
What should the records in the laboratory contain?
resume, training and experience, certification, PRC license, incident report (if any) and other information, which will established the competence of an employee.
What are the technical requirements for licensing?
Physical Plant
Headship of the Lab
Personnel
Lab Equipment
Application Service Provider
What are the technical accreditation requirements?
Records
Security
Chain of Custody
Storage of Lab Reports and Specimens
Urine Specimen Collection, Handling and Disposal
Equipment and instruments
Laboratory Report
Proficiency Testing
Validity of the Test Result
Allowable Service Fee
control access to the premises to ensure that only authorized personnel handle or have access to specimens or gain access to the lab.
Security
The minimum required information on the Chain of Custody are?
Information identifying the specimen
Date and time of the specimen
Name of the testing laboratory
Name of the signatures of all individuals who had custody of the samples during the collection process.
Report pertaining to specimens for laboratory report shall be kept by the testing laboratory for a minimum period determined by DOH which is?
1yr
Specimens can be stored for?
Minimum of 5 days (negative)
15 days (positive but not challenged)
1 year
Who prescribed guidelines in the collection, handling and disposal of specimens?
DOH
What should be must be observed at all times in the specimen collection, handling and disposal?
Universal precautions
What color: Biodegradable waster (food waste)
Green
What color: Non-biodegradable waste (paper, office supply waste)
Black
What color: Infectious waste such as gauze pad contaminated with urine specimen
Yellow
What institutions are needed to collect the biohazard bags?
Partner institutions
Needed equipments in screening lab for accreditation?
Drug Testing Kits
Needed equipments in confirmatory lab for accreditation?
Weighting scale
Glassware’s used in testing (beaker, Erlenmeyer flask, pipettes)
Automatic pipettes
Chromatographs
Spectrometer/Mass Spectrometer
Biological Safety Cabinet
Who are signatories of the lab report?
Analyst who performed the test and the head of the lab
For screening, how should results be reported?
Positive r Negative only since qualitative
For confirmatory, how should results be reported?
Analyte should be reported and concentration and the name of drug
How many copies should be produced for the lab reports?
2 (1 for client, 1 for DOH included with the membrane of the drug test kit)
Who conducts the continuing assessment of proficiency?
NRL
Proficiency testing results must be sent back to the NRL after how many weeks?
3 weeks after rresults
How many allowable failures are there for the proficiency testing?
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
When is a drug test (-) and (+)?
negative drug test result indicates a presence of line, and a positive result is an absence of line.
What is the validity of the Test Result?
1yr
may be used for other purposes
What is the allowable Service Fee?
P 300– Private Hospital/Free Standing Laboratory
P 250– Public Hospital
What must be submitted to DOH via BHFS before certificate of accreditation and license to operate is given?
License to Operate
1. BHFS application form
2. Mayor’s Permit
3. 1 set of floor plan
4. List of personnel, list of credentials, health certificate
5. List of Equipments
6. Contract of License (if facility is rented)
- Copy of DOH license to operate
- 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
What is the Content of License to Operate?
Name of the owner
Head of the Laboratory
Procedures and Specialty
Validity Report
Signature of the Bureau or CHD Director
What is the validity of LTO?
Screening – 1 year
Confirmatory – 2 years
LTO and COA renewal shall be filed how many days before expiration?
90
LTO for renewal should contain?
Application for renewal
Notarized List of Personnel
List of Equipments
Current Certificate of Accreditation
Current Mayor’s Permit
COA for renewal should contain?
- Current license to Operate
- Current Certification for Quality Standard System (Confirmatory Laboratory)
Who conducts the monitoring of labs and when?
CHD director and unannounced
What are the 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
What are violations to RA9165?
- Issuance of fraudulent result
- Failure to protect the confidentiality of a drug test result
- Failure to participate in a proficiency testing
- Failure to refer a positive result to a confirmatory laboratory.
- Refusal to CHD to inspect their laboratory
- Any act which is contrary to the accepted clinical laboratory practice.
What is the penalty for Issuance of False or Fraudulent Drug Test Results?
- Imprisonment: 6 years and 1 day to 12 years AND
- Fine: Php 100, 000. 00 to Php 500, 000. 00
- Additional penalties: revocation of license to practice / closure of drug testing center
If any violation is done under section ____, ______ shall be done. And should not be more than ____ days.
17
preventive suspension
60days
T or F: Labs whose certification of accreditation has been revoked may not issue a new one
F, 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.
Any person apprehended or arrested for violating the provisions of this act shall be subjected to screening laboratory examination within _____
24 hours
If found to be positive, the results of the screening laboratory exam shall be challenged within _____ after the receipt of the result through a___________
15 days
confirmatory test in any accredited laboratory
What is the GOLD standard for confirmatory testing?
Gas chromatography/mass spectrometry
What is the PLATINUM standard?
Liquid chromatography/ mass spectrometry
First time to be (+) for drugs after confirmatory, what happens?
Sent to rehab
Second or more times being (+) for drugs after confirmatory, what happens?
penalized for 6-12yrs
PHP 50,000 - 200,000 fine
When was RA9165 signed? How many sections?
January 23, 2002
102 Sections
Signatories of 9165?
FRANKLIN M. DRILON
President of the Senate
JOSE DE VENECIA, JR.
Speaker of the House of Representatives
Manuel M. Dayrit
Secretary of Health
GLORIA MACAPAGAL-ARROYO
President of the Philippines
What is the Anti-Drunk and Drugged Driving Act of 2013?
RA 10586
A driver of a motor vehicle involved in a vehicular
accident resulting in the loss of human life or physical
injuries shall be subjected to what kind of test?
on site field sobriety test and ABA testing, whenever practicable, and, thereafter chemical tests, including a drug screening test and, if necessary, a drug confirmatory test as mandated under RA 9165
The LTO shall conduct what tests for public utility drivers?
random terminal inspections and quick random drug tests
What act further strengthens the anti-drug campaign of the government?
RA 10640
What section of 9165 does 10640 amend?
21
Signatories of 10640?
FRANKLIN M. DRILON
President of the Senate
FELICIANO BELMONTE JR.
Speaker of the House of Representatives
OSCAR G. YABES
Secretary of the Senate
MARILYN B. BARUA-YAP
Secretary General House of Representatives
BENIGNO S. AQUINO III
President of the Philippines
10640 is in consolidation of?
House Bill 2285 and Senate Bill No. 2273 was finally passed by the House of Representatives and the Senate on June 9, 2014
When was 10640 approved?
July 15, 2014
What should be issued immediately according to 10640?
certification of the forensic laboratory examination results, which shall be done by the forensic laboratory examiner
To implement effectively the provisions of ____, the _______ shall issue the necessary guidelines on the IRR for the purpose in consultation with the _____ and relevant sectors to curb increasing drug cases.
Section 21
Philippine Drug Enforcement Agency (PDEA)
Department of Justice (DOJ)
The ______ or ______ shall get and preserve their representative samples, after their seizure and confiscation, and perform_______ or ______ tests at the site, as far as practicable. The release of the certification or chemistry report shall be after the ________.
seizing officer or forensic chemist
field or screening test
confirmatory test of the samples examined.
