MODULE 9 Flashcards
act instituting the Comprehensive Dangerous Drugs Act of 2002
REPUBLIC ACT NO.9165
what republic act repeals REPUBLIC ACT NO.9165
Republic Act No. 6425
Republic Act No. 6425 also known as
Dangerous Drugs Act of 1972
embraces every kind, class, genus, or specie of the plant Cannabis sativa L.
Cannabis (Marijuana/ Indian Hemp)
two types of drugs that have such chemical composition including any of its isomers/ derivatives
- Methylenedioxymethamphetamine (MDMA)
- Methamphetamine Hydrochloride
Methylenedioxymethamphetamine (MDMA) also known as
Ecstasy
Methylenedioxymethamphetamine (MDMA) also known as
Ecstasy
Methamphetamine Hydrochloride
Shabu/ Ice/ Meth
rapid test performed to establish potential/ presumptive positive result
screening test
analytical test using device, tool/ equip. w/ diff. chemical/physical principle that is more specific which will validate & confirm the result of screening test
confirmatory test
drug testing shall be done by
- govn’t forensic lab
- drug testing lab accredited & monitored by DOH
who sets the price of drug test
DOH w/ DOH accredited drug testing centers
drug testing shall employ 2 testing methods
- screening test
- confirmatory test
drug test certificates issued by accredited drug testing centers shall be valid for
1yr from the date of issue
is tasked to license & accredit drug testing centers in each province & city
DOH
shall accredit physicians who shall conduct the drug dependency examination of a drug dependent as well as the after-care & follow-up program for the said drug dependent
DOH
DOH shall accredit physicians who shall conduct the ________ of a drug dependent as well as the after-care & follow-up program for the said drug dependent
drug dependency examination
DOH shall establish/ operate drug testing centers in
GOVERNMENT HOSPITALS
shall be the policy-making & strategy-formulating body in the planning & formulation of policies & programs on drug prevention & control
BOARD
BOARD shall be under
Office of the President
serves as the implementing arm of the Board, & shall be responsible for efficient & effective law enforcement of all the provisions on any dangerous drug and/or controlled precursor & essential chemical as provided in this Act
PDEA
PDEA stands for
Philippine Drug Enforcement Agency
PDEA stands for
Philippine Drug Enforcement Agency
PDEA is headed by _____ w/ the rank of _____
Director General; undersecretary
Director General of the PDEA shall be appointed by
President of the Philippines
Dangerous Drug Board issued _______
Board Regulation No.2, Series of 2003
Dangerous Drug Board issued Board Regulation No.2, Series of 2003 wherein its subject is on the
Implementing Rules & Regulations Governing Accreditation of Drug Testing Laboratories in the Philippines
three classifications of drug testing tabs
- ownership
- institutional character
- service capability
two types under ownership
government
private
two types under institutional character
institution-based
freestanding
two types under service capability
screening lab
confirmatory lab
operated & maintained by government/ other political unit, or by any department, division, board or agency
government
privately owned, established & operated w/ funds thru donation, principal, investment or other means, by any individual, corporation, association or organization.
private
lab located within the premises & operates as part of an institution
institution-based
lab located outside the premises of an institution & operates independently.
freestanding
lab capable of performing screening tests
screening lab
lab capable of performing qualitative & quantitative examinations of dangerous drugs from specimen
confirmatory lab
give at least two situations that need mandatory drug testing
➔ driver’s license applicants
➔ firearm’s license applicants
give at least two situations that need random drug testing
➔ students of secondary & tertiary schools
➔ officers & employees of public & private offices whether domestic/ overseas
individual from whom a specimen is collected
client/donor
screening lab sqm of floor area
20sqm
screening lab sqm of work area
10sqm
confirmatory lab sqm of floor area
60sqm
confirmatory lab sqm of clinical area
30sqm
lab of whatever category shall have within its premises an area which can receive/ accommodate at least _______________ at a given time
5 prospective clients/donors
DOH-licensed hospital/ non-hospital based Secondary/ Tertiary Category Clinical Lab (intends to put up a Screening Lab for Drug Testing) need to provide an additional ____ to its existing floor area
20sqm
max number of screening labs a physician trained in Clinical Lab Management can handle is ____
ten
max number of screening labs a physician trained in Clinical Lab Management can handle is ten, provided that they are physically feasible w/in _____
5km to supervise
screening lab is headed either by a licensed physician/ chemist/ medtech/ pharmacist/ chem eng: cases where screening drug-testing lab is a _____of clinical lab
division/section/unit
the confirmatory lab is headed by a licensed physician with at least _____yrs of active lab exp in _____
2 years of active lab exp. in analytical toxicology
have the overall responsibility for the professional, organizational, educational and administrative activities of the drug testing facility.
lab head
what type of lab that is required to pass proficiency test, which is to established & administered by NRL
confirmatory lab
A laboratory shall have _______ who shall have the necessary training and skills for the tasks assigned to them
administrative or non-technical personnel
There shall be designated authorized personnel w/in the lab to collect the specimen who must be at least
highschool graduate
The following are persons who are not authorized to collect specimen: (3)
- complainant
- employer of the client/donor
- investigator at the crime scene
IT System Requirements for Confirmatory & Screening Lab
- computer 600MHZ processor 128MB memory 4GB hard disk 56K modern
- printer
- account w/ local internet service provider (ISP)
lab shall have access to one duly authorized _____ approved by DOH selected thru competitive bidding following existing govn’t rules & regulations
Application Service Provider (ASP)
lab shall maintain a record of all its personnel, includes:
- resume of training and experience
- certification or license
- incident reports
exception of ____ all authorized visitors, maintenance and service personnel shall be escorted at all times while inside the lab
duly authorized representative of Bureau,
lab shall maintain a record that indicates
- the date
- time of entry and exit
- purpose of entry of non-employees
lab shall use documented ____ procedures to maintain control & accountability of specimens
chain of custody
min. info. required on Custody & Control Form are
→ Information identifying the specimen
→ Date and time of collection
→ Name of testing laboratory
specimens w/ confirmed positive test results, which are not challenged w/in _____ after receipt be discarded
15 days
specimen may be kept for a max. of ____ upon request
1 year
______ is mandated w/ ff functions for drug testing
East Avenue Medical Center
lab shall have a _____ validated by NRL
procedure manual
certified for accuracy/ be checked by gravimetric, colorimetric or other verification procedures by Department of Science and Technology- Industrial Technology Development Institute
Volumetric pipettes & measuring devices
checked for accuracy & reproducibility before being placed in service & checked periodically
Automatic pipettes & dilutors
Volumetric pipettes & measuring devices: certified for accuracy/ be checked by gravimetric, colorimetric or other verification procedures by
Department of Science and Technology- Industrial Technology Development Institute
standards (e.g. pure reference standards, stock standard solutions, purchased standards) shall be labeled with the following
- date received (if applicable)
- date prepared or opened
- date placed in service & expiration date
test result of an accredited lab shall be in form prescribed by the DOH
screening test result form
all test results shall bear the signature of the analyst and head of laboratory
signatory of test result
Signatory of test result: all test results shall bear the _____ and _____
signature of the analyst & head of laboratory
reporting test results:
reports if negative/positive
screening test result
reporting test results:
reports the presence/absence and the identity of the drug/metabolite tested as well as its concentration
confirmatory test
original copy of test result form: be given to ____ immediately upon its completion
client/donor
submitted for confirmation before a final report will be issued
specimens w/ positive screening test results
test results forwarded to DOH shall include _____ (screening tests)
membrane of registered drug testing kit
test results forwarded to DOH shall include _____ (confirmatory tests)
copy of the chromatogram
results of proficiency test: lab shall submit to NRL the results of the test performed on the unknown sample within _____ after the receipt of the test sample
3 weeks
Failure to pass proficiency test: lab that fails to pass proficiency test conducted by the NRL shall be given another test not earlier than ____ after the failed test
1 month
failure to pass proficiency test shall result in the
suspension of its accreditation
suspension shall be lifted only after passing the
second proficiency test
failure to pass the second proficiency test shall result in the
revocation of its accreditation
drug test certificates on tests performed by accredited drug testing centers shall be valid for _____ from the date of issue, which may be used for other purposes.
1year period
T/F drug-testing lab may collect a reasonable service fee for the performed examination, which shall not be greater than the maximum allowable service fee prescribed by the DOH
TRUE
T/F max. allowable service fees cannot be adjusted from time to time
FALSE
formal authorization issued by DOH to an indiv, partnership, association which has complied w/ all licensing reqs
Accreditation
third party entities that manage & distribute software-based services & solutions to customers across a wide area network from a central data center
Applications Service Provider
procedures to account for each specimen by tracking its handling and storage from point of collection to final disposal
Chain of Custody
within the lab, appropriate chain of custody records must account for the samples until
disposal
designated as NRL for Environmental and Occupational Health, Toxicology and Micronutrient Assay
East Avenue Medical Center (EAMC)
lab capable of doing screening and confirmatory laboratory services, training, and surveillance and external quality assurance program for laboratory tests
East Avenue Medical Center (EAMC)
concentration level set to determine whether the sample is positive or negative for the presence of a drug
Cut Off
applicant accomplishes required docs & submits them to:
____ to exercise the regulatory function
Bureau (Bureau of Health Facilities and Services of the DOH)
applicant accomplishes required docs & submits them to:
____ for endorsement to the Bureau
CHD (Center for Health Development; DOH Regional Field Office)
documentary reqs submitted within the first six months in the Bureau/ CHD for screening lab
Documentation of Quality Control Program
documentary reqs submitted within the first six months in the Bureau/ CHD for confirmatory lab
Certification for Quality Standard System from a DOH-recognized certifying
approves/ disapproves issuance of cert. of accred
Bureau
Bureau approves/ disapproves issuance of cert. of accreditation, if approved:
Bureau registers the lab & issues an initial certificate of accreditation to applicant upon deposit of ____ cash
P20,000
Bureau approves/ disapproves issuance of cert. of accreditation, if disapproved:
Bureau sends the findings and recommendations to the applicant for compliance
if disapproved:
failure to comply within ____shall be a ground for _____
15 days; denial of the application
confirmatory lab fee
P10,000
screening lab fee:
P5000
who is authorized to adjust the accreditation fees from time to time
Bureau
certificate of accreditation is signed by
Bureau or CHD Director
certificate of accreditation for confirmatory lab is valid for
2yrs
certificate of accreditation for screening lab is valid for
1yr
renewal certificate of accreditation shall be filed ____ days before the expiry date to Bureau & CHD
90 days
T/F monitoring visits shall be conducted unannounced
TRUE
monitoring visits shall document the
overall quality of the lab setting
accreditation that is not renewed on the expiry date shall be considered
lapsed & registration shall be cancelled.
Failure to report in writing within 15days of any substantial change in condition of the lab may be a basis for the ____ of the accreditation.
suspension or revocation
shall be required for all labs/ branches maintained in separate premises but operated under the same management
SEPARATE ACCREDITATION
give at least three violations
➔ Issuance of false or fraudulent drug test results
➔ Failure to protect the confidentiality of drug test results
➔ Failure to participate or pass the proficiency testing
→preventive suspension: not be more than __ days
60
T/F: if upon survey/ monitoring visits, drug testing lab is found to be violating the rules and regulations as well as other violations, Bureau may immediately preventively suspend the operation of the said lab
true
