MODULE 9 Flashcards

1
Q

act instituting the Comprehensive Dangerous Drugs Act of 2002

A

REPUBLIC ACT NO.9165

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2
Q

what republic act repeals REPUBLIC ACT NO.9165

A

Republic Act No. 6425

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3
Q

Republic Act No. 6425 also known as

A

Dangerous Drugs Act of 1972

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4
Q

embraces every kind, class, genus, or specie of the plant Cannabis sativa L.

A

Cannabis (Marijuana/ Indian Hemp)

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5
Q

two types of drugs that have such chemical composition including any of its isomers/ derivatives

A
  • Methylenedioxymethamphetamine (MDMA)
  • Methamphetamine Hydrochloride
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6
Q

Methylenedioxymethamphetamine (MDMA) also known as

A

Ecstasy

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6
Q

Methylenedioxymethamphetamine (MDMA) also known as

A

Ecstasy

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7
Q

Methamphetamine Hydrochloride

A

Shabu/ Ice/ Meth

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8
Q

rapid test performed to establish potential/ presumptive positive result

A

screening test

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9
Q

analytical test using device, tool/ equip. w/ diff. chemical/physical principle that is more specific which will validate & confirm the result of screening test

A

confirmatory test

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10
Q

drug testing shall be done by

A
  • govn’t forensic lab
  • drug testing lab accredited & monitored by DOH
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11
Q

who sets the price of drug test

A

DOH w/ DOH accredited drug testing centers

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12
Q

drug testing shall employ 2 testing methods

A
  • screening test
  • confirmatory test
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13
Q

drug test certificates issued by accredited drug testing centers shall be valid for

A

1yr from the date of issue

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14
Q

is tasked to license & accredit drug testing centers in each province & city

A

DOH

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15
Q

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

A

DOH

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16
Q

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

A

drug dependency examination

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17
Q

DOH shall establish/ operate drug testing centers in

A

GOVERNMENT HOSPITALS

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18
Q

shall be the policy-making & strategy-formulating body in the planning & formulation of policies & programs on drug prevention & control

A

BOARD

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19
Q

BOARD shall be under

A

Office of the President

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20
Q

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

A

PDEA

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21
Q

PDEA stands for

A

Philippine Drug Enforcement Agency

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21
Q

PDEA stands for

A

Philippine Drug Enforcement Agency

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22
Q

PDEA is headed by _____ w/ the rank of _____

A

Director General; undersecretary

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23
Q

Director General of the PDEA shall be appointed by

A

President of the Philippines

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24
Q

Dangerous Drug Board issued _______

A

Board Regulation No.2, Series of 2003

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25
Q

Dangerous Drug Board issued Board Regulation No.2, Series of 2003 wherein its subject is on the

A

Implementing Rules & Regulations Governing Accreditation of Drug Testing Laboratories in the Philippines

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26
Q

three classifications of drug testing tabs

A
  • ownership
  • institutional character
  • service capability
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27
Q

two types under ownership

A

government
private

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28
Q

two types under institutional character

A

institution-based
freestanding

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29
Q

two types under service capability

A

screening lab
confirmatory lab

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30
Q

operated & maintained by government/ other political unit, or by any department, division, board or agency

A

government

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31
Q

privately owned, established & operated w/ funds thru donation, principal, investment or other means, by any individual, corporation, association or organization.

A

private

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32
Q

lab located within the premises & operates as part of an institution

A

institution-based

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33
Q

lab located outside the premises of an institution & operates independently.

A

freestanding

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34
Q

lab capable of performing screening tests

A

screening lab

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35
Q

lab capable of performing qualitative & quantitative examinations of dangerous drugs from specimen

A

confirmatory lab

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36
Q

give at least two situations that need mandatory drug testing

A

➔ driver’s license applicants
➔ firearm’s license applicants

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37
Q

give at least two situations that need random drug testing

A

➔ students of secondary & tertiary schools
➔ officers & employees of public & private offices whether domestic/ overseas

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38
Q

individual from whom a specimen is collected

A

client/donor

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39
Q

screening lab sqm of floor area

A

20sqm

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40
Q

screening lab sqm of work area

A

10sqm

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41
Q

confirmatory lab sqm of floor area

A

60sqm

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42
Q

confirmatory lab sqm of clinical area

A

30sqm

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43
Q

lab of whatever category shall have within its premises an area which can receive/ accommodate at least _______________ at a given time

A

5 prospective clients/donors

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44
Q

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

A

20sqm

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45
Q

max number of screening labs a physician trained in Clinical Lab Management can handle is ____

A

ten

46
Q

max number of screening labs a physician trained in Clinical Lab Management can handle is ten, provided that they are physically feasible w/in _____

A

5km to supervise

47
Q

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

A

division/section/unit

48
Q

the confirmatory lab is headed by a licensed physician with at least _____yrs of active lab exp in _____

A

2 years of active lab exp. in analytical toxicology

49
Q

have the overall responsibility for the professional, organizational, educational and administrative activities of the drug testing facility.

A

lab head

50
Q

what type of lab that is required to pass proficiency test, which is to established & administered by NRL

A

confirmatory lab

51
Q

A laboratory shall have _______ who shall have the necessary training and skills for the tasks assigned to them

A

administrative or non-technical personnel

52
Q

There shall be designated authorized personnel w/in the lab to collect the specimen who must be at least

A

highschool graduate

53
Q

The following are persons who are not authorized to collect specimen: (3)

A
  • complainant
  • employer of the client/donor
  • investigator at the crime scene
54
Q

IT System Requirements for Confirmatory & Screening Lab

A
  • computer 600MHZ processor 128MB memory 4GB hard disk 56K modern
  • printer
  • account w/ local internet service provider (ISP)
55
Q

lab shall have access to one duly authorized _____ approved by DOH selected thru competitive bidding following existing govn’t rules & regulations

A

Application Service Provider (ASP)

56
Q

lab shall maintain a record of all its personnel, includes:

A
  • resume of training and experience
  • certification or license
  • incident reports
57
Q

exception of ____ all authorized visitors, maintenance and service personnel shall be escorted at all times while inside the lab

A

duly authorized representative of Bureau,

58
Q

lab shall maintain a record that indicates

A
  • the date
  • time of entry and exit
  • purpose of entry of non-employees
59
Q

lab shall use documented ____ procedures to maintain control & accountability of specimens

A

chain of custody

60
Q

min. info. required on Custody & Control Form are

A

→ Information identifying the specimen
→ Date and time of collection
→ Name of testing laboratory

61
Q

specimens w/ confirmed positive test results, which are not challenged w/in _____ after receipt be discarded

A

15 days

62
Q

specimen may be kept for a max. of ____ upon request

A

1 year

63
Q

______ is mandated w/ ff functions for drug testing

A

East Avenue Medical Center

64
Q

lab shall have a _____ validated by NRL

A

procedure manual

65
Q

certified for accuracy/ be checked by gravimetric, colorimetric or other verification procedures by Department of Science and Technology- Industrial Technology Development Institute

A

Volumetric pipettes & measuring devices

66
Q

checked for accuracy & reproducibility before being placed in service & checked periodically

A

Automatic pipettes & dilutors

67
Q

Volumetric pipettes & measuring devices: certified for accuracy/ be checked by gravimetric, colorimetric or other verification procedures by

A

Department of Science and Technology- Industrial Technology Development Institute

68
Q

standards (e.g. pure reference standards, stock standard solutions, purchased standards) shall be labeled with the following

A
  • date received (if applicable)
  • date prepared or opened
  • date placed in service & expiration date
69
Q

test result of an accredited lab shall be in form prescribed by the DOH

A

screening test result form

70
Q

all test results shall bear the signature of the analyst and head of laboratory

A

signatory of test result

71
Q

Signatory of test result: all test results shall bear the _____ and _____

A

signature of the analyst & head of laboratory

72
Q

reporting test results:
reports if negative/positive

A

screening test result

73
Q

reporting test results:
reports the presence/absence and the identity of the drug/metabolite tested as well as its concentration

A

confirmatory test

74
Q

original copy of test result form: be given to ____ immediately upon its completion

A

client/donor

75
Q

submitted for confirmation before a final report will be issued

A

specimens w/ positive screening test results

76
Q

test results forwarded to DOH shall include _____ (screening tests)

A

membrane of registered drug testing kit

77
Q

test results forwarded to DOH shall include _____ (confirmatory tests)

A

copy of the chromatogram

78
Q

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

A

3 weeks

79
Q

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

A

1 month

80
Q

failure to pass proficiency test shall result in the

A

suspension of its accreditation

81
Q

suspension shall be lifted only after passing the

A

second proficiency test

82
Q

failure to pass the second proficiency test shall result in the

A

revocation of its accreditation

83
Q

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.

A

1year period

84
Q

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

A

TRUE

85
Q

T/F max. allowable service fees cannot be adjusted from time to time

A

FALSE

86
Q

formal authorization issued by DOH to an indiv, partnership, association which has complied w/ all licensing reqs

A

Accreditation

87
Q

third party entities that manage & distribute software-based services & solutions to customers across a wide area network from a central data center

A

Applications Service Provider

88
Q

procedures to account for each specimen by tracking its handling and storage from point of collection to final disposal

A

Chain of Custody

89
Q

within the lab, appropriate chain of custody records must account for the samples until

A

disposal

90
Q

designated as NRL for Environmental and Occupational Health, Toxicology and Micronutrient Assay

A

East Avenue Medical Center (EAMC)

91
Q

lab capable of doing screening and confirmatory laboratory services, training, and surveillance and external quality assurance program for laboratory tests

A

East Avenue Medical Center (EAMC)

92
Q

concentration level set to determine whether the sample is positive or negative for the presence of a drug

A

Cut Off

93
Q

applicant accomplishes required docs & submits them to:
____ to exercise the regulatory function

A

Bureau (Bureau of Health Facilities and Services of the DOH)

94
Q

applicant accomplishes required docs & submits them to:
____ for endorsement to the Bureau

A

CHD (Center for Health Development; DOH Regional Field Office)

95
Q

documentary reqs submitted within the first six months in the Bureau/ CHD for screening lab

A

Documentation of Quality Control Program

96
Q

documentary reqs submitted within the first six months in the Bureau/ CHD for confirmatory lab

A

Certification for Quality Standard System from a DOH-recognized certifying

97
Q

approves/ disapproves issuance of cert. of accred

A

Bureau

98
Q

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

A

P20,000

99
Q

Bureau approves/ disapproves issuance of cert. of accreditation, if disapproved:

A

Bureau sends the findings and recommendations to the applicant for compliance

100
Q

if disapproved:
failure to comply within ____shall be a ground for _____

A

15 days; denial of the application

101
Q

confirmatory lab fee

A

P10,000

102
Q

screening lab fee:

A

P5000

103
Q

who is authorized to adjust the accreditation fees from time to time

A

Bureau

104
Q

certificate of accreditation is signed by

A

Bureau or CHD Director

105
Q

certificate of accreditation for confirmatory lab is valid for

A

2yrs

106
Q

certificate of accreditation for screening lab is valid for

A

1yr

107
Q

renewal certificate of accreditation shall be filed ____ days before the expiry date to Bureau & CHD

A

90 days

108
Q

T/F monitoring visits shall be conducted unannounced

A

TRUE

109
Q

monitoring visits shall document the

A

overall quality of the lab setting

110
Q

accreditation that is not renewed on the expiry date shall be considered

A

lapsed & registration shall be cancelled.

111
Q

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.

A

suspension or revocation

112
Q

shall be required for all labs/ branches maintained in separate premises but operated under the same management

A

SEPARATE ACCREDITATION

113
Q

give at least three violations

A

➔ 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

114
Q

→preventive suspension: not be more than __ days

A

60

114
Q

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

A

true