RA 9165 Flashcards
title and scope of RA 9165
Comprehensive Dangerous Drugs Act of 2002
- these rules and regulations shld apply to all drug testing laboratories, whether government-run or private.
*a law to control and prevent illegal drug activities in the Philippines.
what law did the RA 9165 replace?
RA 6425, the “Dangerous Drugs Act of 1972”
How many sections does RA 9165 have
102 sections
however, the ones presented are
- the implementing rules and regulations governing licensing
- accreditation of drug testing lab in the Philippines
true or false: medical technologist can work as as drug testing analysts (DTA)
true
What law and executive order provide authority for these rules?
Republic Act 9165 consistent with EO 102 s 1999
- which define the responsibilities of the Department of Health (DOH)
what government department oversees drug testing regulations?
DOH
any act of introducing any dangerous drug into the body of any person, with or without his/ her knowledge
administer
- injection
- inhalation
- ingestion
what is an S2 license for
to supply dangerous drugs as some additives used is dangerous
it refers to the professional who perform the drug testing
analyst
it refers to the owner r head of the laboratory that is applying for the issuance of a license/ accreditation
applicant
it refers to the third-party entities that manage and distribute software-based services
application service provider
IDTOMIS stands for
Integrated Drug Test Operation and Management Information System.
- it is registered with the DOH
how does IDTOMIS work
Fingerprint Registration:
Every client must scan their fingerprint and set up an account in the system.
Unique Identity:
Each person must have a unique registration using their fingerprint to prevent duplicate records.
Third-Party Involvement:
A separate organization may help manage or verify the system to ensure accuracy and security.
who are the 4 professionals who can be a certified drug test analyst
- registered medical technologist
- not all med techs can be DTA
- need to have a 3 day seminar in order to become a DTA - pharmacist
- chemist
- chemical engineers
it refers to the person who is authorized to collect specimen from the client to secure and prevent alteration of urine specimen
authorized specimen collector
- follows you to collect specimen to ensure that you did not alter
it refers to the Bureau of Health Facilities an service located at DOH
Bureau
an 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
confirmatory test
what happens if the screening test is positive
the person is subjected to confirmatory test
it refers to the procedure to account for each specimen by tracking the handling and storage from point of collection to final disposal. this procedure require that the applicant’s identity is confirmed and that a chain of custody form that is used from the time of collection to receipt by the laboratory
chain of custody
it refers to the form used to document the procedures from the time of collection until receipt by the laboratory
chain of custody form
it includes those listed in the schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol and in the schedules annexed to the 1971 Single Convention on Psychotropic Substances as enumerated in the attached annex which is an integral part of this Act.
dangerous drug
- there are 100 tpes
-most common:
Methamphetamine (“Shabu”)
Tetrahydrocannabinol (THC) in Marijuana
(widely distributed in the country)
it specializes environmental and Occupational Health, Toxicology and Micronutrient assay designated by the Secretary of Health.
It is a Laboratory capable of doing screening and confirmatory laboratory services, surveillance and training, external quality result is challenged, the NRL shall make the final decision.
NRL, National Reference Laboratory
- it is located on East Avenue and has the final say on test result
what does NRL do
confirm test result
- they have the final say if test results are challenged
provides training for DTA
ensures lab quality
conducts specialized tests
A rapid test performed to establish potential/presumptive positive result. Qualitative test.
screening test
Refers to the body fluid that is collected from a person.
specimen
PDEA
Philippine Drug Enforcement Agency
true or false:
screening test measure the amount of drug in the body
false - they do not
they only checks if drugs are present or not
SOC for screening test
urine sample
- at least 60mL required
- if +ve, the sample is sent for confirmatory testing to verify the result, hence need enough urine
classification of drugs
By Ownership
- government
- private
By Institutional Character
- institutional based
- freestanding
By Service Capability
- screening laboratory
- confirmatory laboratory
*in screening, we don’t quantify but in confirmatory test we do
it is operated and maintained partially or wholly by the provincial, city or municipal government or other political unit or by department, division, board or agency
government drug testing laboratory
it is privately owned, established and operated with funds through donation, principal investments or other means, by any individual,
corporation, association or organization.
private drug testing laboratory
it is a laboratory that is located within the premises and operates as a part of an institution (hospital, medical facilities for OFW)
institutional based
it is a laboratory that is located outside the premises of an institution and operates independently.
freestanding
- outside an institution
a laboratory that is capable of performing screening test
screening laboratory
a laboratory capable of performing qualitative and quantitative examinations of dangerous drugs
confirmatory laboratory
who of the following needs to undergo drug testing
- Applicants for Driver’s License
- 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 am impossible penalty of imprisonment of not less than 6years and 1day
(people charged w serious crimes) - Persons apprehended for the violations of this act
!! there r random drug testing for application of driver’s license
What criminal offenses require drug testing?
crimes w punishment of at least 6 years & 1 day in prison
Who is subject to Random Drug Testing?
- Students of Secondary or Tertiary schools
- Officers and employee of public, private and private offices whether domestic or oversees.
Where are hospital drug test samples sent?
to the NRL, national reference laboratory
*hospitals conduct drug testing to ensure healthcare workers & patients are drug-free
what are the technical requirements for Licensing a Drug Laboratory Testing
A. Physical Plant
- screening lab
- confirmatory lab
B. Headship of the Laboratory
C. Personnel
- screening lab
- confirmatory lab
D. Laboratory Equipment
- screening lab
- confirmatory lab
E. Application Service Provider
what are the technical requirements for Accreditation
- Records
- Security
- Chain of Custody
- Storage of Laboratory Reports and Specimens
- Test Level - Urine Specimen Collection, Handling and Disposal
- Equipment and instruments
- Laboratory Report
- Proficiency Testing
physical plant of
screening lab vs confirmatory lab
screening lab:
- at least 20sqm in floor area
- work area must be at least 10sqm with:
exhaust fan
sink
storage cabinet
ref
confirmatory lab:
- at least 60sqm in floor area
- clinical work area must have at least 30sgm with:
- exhaust fan
- sink
- stock room
- instrumentation room
*the confirmatory lab shld be bigger than the screening
what are the requirements of a laboratory of whatever category shall have within its premises
an area which can receive or accommodate
- at least 5 clients at a time
- include hand washing facility, toilet facility and a stall for the collection of the specimen
[to prevent tampering]
Who can be the Head of the Laboratory?
Licensed physician certified in Clinical Pathology
- by the Philippine Board of Pathology
If not available, a licensed physician with training in Clinical Laboratory Management.
What if no clinical pathologist is available?
A physician with Clinical Lab Management training can qualify.
true or false:
A chemist can be the lab head
true
as long as they have
- Master’s Degree in Chemistry, Biochemistry or Branch of chemistry
- with at least 2 years of experience in analytical chemistry
*certificate & proof of Master’s Degree are required
personnel in
screening lab vs confirmatory lab
SCREENING LAB
full time
- medical technologist
- chemist
- pharmacist
- chemical engineer
*w appropriate training in screening procedures for dangerous drugs
CONFIRMATORY LAB
full time
- medical technologist
- chemist
- pharmacist
- chemical engineer
*who has completed extensive appropriate training in chromatography and spectroscopy (analyst must pass the proficiency test!)
who else works in a drug lab? (other personnel)
- Secretary
- Authorized Specimen Collector
- shld be a high sch graduate& hv training
what is requires to become a DTA, drug test analyst
3-day training
have Certification
true or false:
The Laboratory shall have administrative personnel or non-technical personnel who shall be trained for the assigned work.
true
[ Administrative personnel (office staff handling paperwork & records).
Non-technical personnel (assist in lab operations but do not perform tests).
*they must be trained for specific tasks]
laboratory equipment in
screening lab vs
confirmatory lab
SCREENING LAB
- shall hv necessary equipment or kit
CONFIRMATORY LAB
- shall hv necessary equipment for screening, qualitative and quantitative examination in addition to the basic equipment
[screening - basic equipment
confirmatory - advanced equipment for qualitative and quantitative testing]
the lab shall have access to an Application Service Provider approved by the DOH for the authentication of results
ASP, Application Service Provider
- ensures secure storage & access to drug test results
- verifies if a person passed or failed their drug test
*for the lab to get ASP approval: apply & be approved before using the system
The Laboratory shall maintain a record of all of its personnel. The records must include the resume, training and experience, certification, PRC license, incident report (if any) and other information, which will established the competence of an employee.
record
The laboratory shall have security measures to control access to the premises to ensure that only authorized personnel handle or have access to specimens or gain access to the lab.
security
what records must a drug testing lab keep?
resume
training
PRC license
certification
incident reports
other proof of competence
who are allowed to bypass security
- authorized inspectors for DOH
- maintenance of IDTIOMS
- Inspectors
*they shld record in the log book (time in & out)
What is the Chain of Custody?
A documented process that tracks a specimen from collection to final testing.
what are the minimum information is required in the Chain of Custody?
- 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
How long should laboratory reports be stored?
at least 1 year per DOH guidelines
How long should specimens be stored?
minimum of 5 days - 1 year
- Positive specimens: At least 15 days (up to 1 year)
- Negative specimens: 5 days to 1 year
*additives are used in specimens to preserve and extend their storage life
Who sets the cut-off levels for drug tests?
NRL (National Reference Laboratory) sets the cut-off levels for screening specimens.
- the equipment & drug testing kits must be registered in IDTOMIS.
*brand name and expiration date must be registered in IDTOMIS for it to be tracked
What must be registered in IDTOMIS?
Equipment & drug testing kits must be registered in IDTOMIS.
cut-off requirements of DOH
transes
What must be followed for urine specimen handling?
DOH guidelines for collection, handling, and disposal of specimens
- universal precautions must be observed
What types of waste are there in a drug testing lab?
Green:
Biodegradable waste (e.g., food waste).
Black:
Non-biodegradable waste (e.g., paper).
Infectious waste:
Contaminated items like gauze
what are the equipment and instruments is needed for
screening lab vs confirmatory lab
SCREENING LAB
Drug Testing Kits
CONFIRMATORY LAB
Weighing scales
Glassware used in testing (beakers, pipettes, Erlenmeyer flasks)
Chromatographs
Spectrometer/ Mass Spectrometer
Biological Safety Cabinet
what must the laboratory test result form include?
test result form shall prescribed by DOH
signatory must be the analyst who performed the test and also the head of lab
(IDTOMIS can print the form and also view there)
how are results reported in
confirmatory tests vs screening tests
screening tests:
+ve or -ve
confirmatory tests:
analyte (substance) and concentration (amount)
*test result copies: 2 total
- 1 copy fr client
- 1 copy forwarded to DOH and must include the membrane of drug test kit
what must accompany the confirmatory test results that will be passed to DOH
details abt the drug test kit
- tgt w the copy of test result
when NRL conducts continuing assessments of the proficiency of both Screening and Confirmatory Laboratories.
proficiency testing
- labs must participate and satisfactorily pass the proficiency tests to renew their license.
[an ongoing assessment of lab skills by NRL to ensure testing accuracy n maintain lab license]
How long does a lab have to send proficiency test results back to NRL?
within 3 weeks after the results
- failure to pass shall be given another chance, however, failure to pass the 2nd time = revocation of its license and accreditation
proficiency test procedure
the lab receives 10 sets of synthetic urine.
analyst tests for drugs of abuse.
results must be read within 5 minutes to be valid.
(read after 5 min = false positive)
How are drug test results interpreted?
Negative: 2 lines
Positive: 1 line
(Unlike pregnancy tests, a -ve drug test result shows two lines = not present.
A +ve result shows one line = present)
how does the drug testing report look like
transes
how long is the drug certificate valid
1 year from date of issue
What are the service fees for drug testing?
₱300: Private Hospitals/Free-standing Labs
₱250: Public Hospitals
What documents must be submitted for license to operate?
License to operate:
BHFS application form
Mayor’s Permit
1 set of Floor Plan
List of personnel, credentials and health certificate
List of equipment
Contract of License (if rented)
What documents are needed for accreditation?
- License to operate
- 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
the fees for renewal of license
confirmatory lab vs screening lab
- license fee
- accreditation fee
*shld be paid to the cashier of the DOH
CONFIRMATORY LAB
license fee: 5,000
accreditation fee: 5,000
SCREENINNG LAB
license fee: 2,000
accreditation fee: 5,000
what are 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
true or false:
head of the lab is the owner of the lab
false - not necessarily the owner (must be qualified professional such as pathologist or someone w similar qualifications)
What is the validity period for screening and confirmatory licenses?
Screening License: 1 year
Confirmatory License: 2 years
what documents are required for renewal of the License to Operate?
Application for renewal
Notarized list of personnel
List of equipment
Current certificate of accreditation
Current Mayor’s Permit
*it shall be filled 90 days before the expiration of license
who may conduct a visit on the site (Laboratory) unannounced and monitoring shall be documented the overall quality of the laboratory setting
The bureau or the CHD
what are the terms and conditions of Licensing/Accreditation
- 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
violations
- 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 happens after an inspection or complaint regarding a laboratory?
DOH will conduct an investigation and suspend or revoke the license depending on the findings.
What is preventive suspension?
If a violation is found, preventive suspension can be imposed
- lasting no more than 60 days.
Reapplication for License to Operate/Certificate of Accreditation
if a lab’s certificate is revoked
- can reapply for a new certificate after meeting the necessary requirements
- correcting any violations or deficiencies
what are the Penalties for Violations
Imprisonment: 6 years and 1 day to 12 years
Fines: ₱100,000 - ₱500,000
Revocation of License: The PRC may recommend the revocation of a drug analyst’s license if they are found guilty of violations.
If any section or provision of the law is declared invalid or unconstitutional, the rest of the law will still remain in effect.
section 22: Separability Clause
how can a lab appeal
If a laboratory or any of its personnel is dissatisfied with a decision (such as suspension), they can appeal the decision.
The appeal must be filed within 15 days after receiving the notice of suspension.
The appeal will be reviewed by the Secretary of Health.
effectivity of RA 9165
approved on January 13, 2003
who approved RA 9165
Franklin M. Drilon, President of the Senate
Jose de Venecia, Jr., Speaker of the House of Representatives
Manuel M. Dayrit, Secretary of Health
Roberto P. Nazareno, Secretary General, House of Representatives
Gloria Macapagal-Arroyo, President of the Philippines
