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MIDTERM - MTLAWS > MODULE 9 > Flashcards

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 ____

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.

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

62
Q

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

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

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

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

85
Q

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

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

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

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

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

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

102
Q

screening lab fee:

103
Q

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

104
Q

certificate of accreditation is signed by

A

Bureau or CHD Director

105
Q

certificate of accreditation for confirmatory lab is valid for

106
Q

certificate of accreditation for screening lab is valid for

107
Q

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

108
Q

T/F monitoring visits shall be conducted unannounced

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

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

MIDTERM - MTLAWS (8 decks)

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