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MTLws > (1) UNIT 2: RA 4688 > Flashcards

(1) UNIT 2: RA 4688 Flashcards

1
Q

RA 4688 is otherwise known as ___

A

Clinical Laboratory Law

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2
Q

RA6488 is comprised of how many sections?

A

8

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3
Q

RA4688 is approved on ___

A

June 18, 1966

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4
Q

An Act Regulating the Operation and Maintenance of Clinical Laboratories of Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation thereof, and for other purposes

A

RA 4688; Clinical Laboratory Law

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5
Q

Identify the Section of RA4688:

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions, and radioactivity from humans or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health: Provided, That government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories.

A

Section 1

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6
Q

Identify the Section of RA4688:

It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually.

A

Section 2

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7
Q

Identify the Section of RA4688:

No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician as provided for in the preceding paragraph.

A

Section 2

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8
Q

Identify the Section of RA4688:

The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.

A

Section 3

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9
Q

Identify the Section of RA4688:

Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court.

A

Section 4

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10
Q

Identify the Section of RA4688:

If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof.

A

Section 5

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11
Q

Identify the Section of RA4688:

The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act.

A

Section 6

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12
Q

Identify the Section of RA4688:

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

A

Section 7

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13
Q

Identify the Section of RA4688:

This Act shall take effect upon its approval.

A

Section 8

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14
Q

Amendment of RA4688 that redirects the functions and operations of DOH

A

EO no. 102, s. 1999

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15
Q

Amendment of RA4688 which states the rule and regulations governing the establishment, operation, and maintenance of clinical laboratories in the Philippines

A

AO no. 59, s. 2001

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16
Q

Implementing guideline of RA4688 that provides the revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines

A

AO no. 27, s. 2007
AO No. 2007-0027

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17
Q

Implementing guideline of RA4688 that amends AO 2007-0027

A

AO No. 2007-0027-A

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18
Q

Implementing guidelines of RA4688 that mandates the posting of schedule of fees for laboratory and other diagnostic services of hospitals and other health facilities

A

AO No. 2008-0002

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19
Q

Implementing guidelines of RA4688 that mandates the posting of schedule of fees for the licensure of general clinical laboratories and the registration of special clinical laboratories

A

AO No. 2008-0007

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20
Q

New rules and regulation governing the regulation of clinical laboratories in the Philippines that is used at present and is updated related to COVID-19

A

AO No. 2021-0037

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21
Q

Specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories

A

Health Facilities & Services Regulatory Bureau

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22
Q

Health Facilities & Services Regulatory Bureau is formerly known as ___

A

Bureau of Health Facilities & Services (BHFS)

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23
Q

In charge of all clinical laboratory licensing and related concerns

A

Health Facilities and Service Regulatory Bureau (HFSRB)

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24
Q

Region-based licensing and regulation division of HFSRB

A

Regulatory Licensing Enforcement Division (RLED)

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25
Q

AO 2021-0037 is signed by ___

A

Former DOH Sec. Francisco Duque

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26
Q

Provides the necessity to revies the current AO and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned to RA11223 which is to guarantee access to quality and affordable health products, devices, facilities, and services

A

AO 2021-0037

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27
Q

Identify the term:

Natural or judicial person who intends to operate a clinical laboratory

A

Applicant

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28
Q

What does HFSRB mean?

A

Health Facilities and Services Regulatory Bureau

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29
Q

What does CHD mean?

A

Center for Health Development

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30
Q

Identify the term:

Facility where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis, and treatment of disease

A

Clinical Laboratory

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31
Q

Identify the term:

Panic values originally described by Lundberg as “life-threatening” unless something is done promptly and for which some corrective action could be undertaken

A

Critical Values

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32
Q

What does DOH mean?

A

Department of Health

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33
Q

What does EQAP mean?

A

External Quality Assessment Program

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34
Q

Program where participating laboratories are given unknown samples for analysis

A

External Quality Assessment Program (EQAP)

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35
Q

Identify the term:

Checklist used by regulatory officers during inspection visits to evaluate compliance of clinical laboratory to minimum standards and technical requirements

A

Assessment tool

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36
Q

Assessment tool for licensing a general clinical laboratory

A

AO 2021-0037 Annex B1

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37
Q

Equipment/instruments/glassware/supplies/reagents per area of activity/service capability of general clinical laboratory

A

AO 2021-0037 Annex B2

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38
Q

Prohibited acts in the operations of clinical laboratories

A

AO 2021-0037 Annex C

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39
Q

Planning and design guidelines for general clinical laboratory

A

AO 2021-0037 Annex D1

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40
Q

Checklist for review of floor plans general clinical laboratory

A

AO 2021-0037 Annex D2

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41
Q

Guidelines in securing for remote collection permit for clinical laboratories

A

AO 2021-0037 Annex E

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42
Q

Application form for certificate of registration for research and teaching clinical laboratory

A

AO 2021-0037 Annex F

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43
Q

Identify the term:

Corporate body or establishment organized for an educational, medical, charitable or similar purpose

A

Institution

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44
Q

Identify the term:

Issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the requirements set forth

A

License

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45
Q

Identify the term:

Individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance

A

Licensee

46
Q

Identify the term:

Also refers to the license

A

License to Operate (LTO)

47
Q

Identify the term:

Laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location; shall have a base laboratory

A

Mobile Clinical Laboratory

48
Q

Identify the term:

Tests done in series of patients as a guide for treatment or follow-up of their condition

A

Monitoring Examinations

49
Q

T/F: mobile clinical laboratories do not need base laboratories as they are already equipped enough

A

F

50
Q

Identify the term:

Laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas

A

National Reference Laboratory (NRL)

51
Q

NRL for hematology, immunohematology, urinalysis

A

National Kidney and Transplant Institute (NKTI)

52
Q

NRL for serology

A

STD/AIDS Central Cooperative Laboratory (SACCL)

53
Q

NRL for Clinical Chemistry

A

Lung Center of the Philippines (LCP)

54
Q

NRL for drug testing, water microbiology, micronutrient assay

A

East Avenue Medical Center (EAMC)

55
Q

NRL for microbiology and parasitology

A

Research Institute of Tropical Medicine (RITM)

56
Q

Identify the term:

Individual doctor’s office/clinic wherein laboratory examinations are performed

A

Physician’s Office Laboratory (POL)

57
Q

Identify the term:

Diagnostic testing at or near the site of patient care rather than in clinical laboratory; includes bedside testing, outpatient and home care

A

Point of Care Testing (POCT)

58
Q

Identify the term:

Basic, commonly requested tests in the laboratory, the result of which are not required to be released immediately upon completion

A

Routine Tests

59
Q

Identify the term:

Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory

A

Satellite Testing Site

60
Q

Identify the term:

Done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure

A

STAT tests

61
Q

STAT is an abbreviation for ___ which means immediateley

A

sta’tim

62
Q

Meaning of STAT

A

Short turn around time

63
Q

Two classifications of laboratories based on ownership

A

Government
Private

64
Q

Operated and maintained, partially or wholly, by the national government, a local government unit, any other political unit or any department, division, board or agency thereof

A

Government Laboratories

65
Q

Owned, established, and operated by any individual, corporation, association, or organization

A

Private Laboratories

66
Q

Classification of laboratories based on function

A

Clinical Pathology
Anatomic Pathology

67
Q

Includes clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, endocrinology, molecular biology, cytogenetics, toxicology and therapeutic drug monitoring and other similar disciplines

A

Clinical Pathology

68
Q

Includes surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology, and molecular pathology

A

Anatomic Pathology

69
Q

Classifications of laboratories based on institutional character

A

Institution based
Free-standing

70
Q

A laboratory that operates within the premises and as part of an institution, such as but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center

A

Institution based laboratory

71
Q

A laboratory that does not form part of any other institution

A

Free-standing

72
Q

Types of general clinical laboratory

A

Primary
Secondary
Tertiary
Limited Service Capability (institution-based)

73
Q

A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory

A

Special Clinical Laboratory

74
Q

Provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics

A

Limited Service Capability Laboratory

75
Q

T/F: clinical laboratories exclusive for research and teaching purposes shall be exempted from the licensing requirement but shall be required to register

A

T

76
Q

T/F: NRLs have different licensing process aside from the clinical laboratory of the hospital

A

F (it is already covered by the license of the hospital)

77
Q

POL is required to secure a LTO when it undertakes any or all of which activities?

A
  1. issue official laboratory results
  2. perform more than monitoring examinations
  3. cater not only to the physician’s own patients
78
Q

T/F: POCT (in hospital) required of licensing under management of clinical laboratory

A

T

79
Q

Head of laboratory

A

Pathologist

80
Q

Minimum duty in laboratories

A

4 MTs for 8 hours (3 for each 8 hours + 1 reliever)
3 MTs for 12 hours (2 for each 12 hours + 1 reliever)

81
Q

Minimum technical working area for physical facilities according to AO 2007-0027

A

Primary: 10 sq m
Secondary: 20 sq m
Tertiary: 60 sq m

82
Q

Criteria for renewal of license

A

Satisfactory performance rating

83
Q

Basis for suspension/revocation of license

A

Refusal to participate in EQAS-NRL

84
Q

Recordings should be kept in file for at least ___

A

1 year

85
Q

Anatomic and forensic pathology reports are kept for ___

A

Permanently kept

86
Q

Schedule of renewal of LTO

A

First day of October to last day of November

87
Q

Renewal of LTO should be processed not later than ___ after expiration date of LTO

A

5 working days

88
Q

T/F: LTO is automatically cancelled without notice when there is a failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in the license

A

T

89
Q

Shall conduct announced inspections at any reasonable time

A

Center for Health Development (CHD)

90
Q

Prescribes the standards, criteria, and technical requirements for the issuance of LTO

A

Inspection tool/Self assessment tool

91
Q

___ shall investigate the complaint

A

HFSRB/CHD Director

92
Q

1st offense penalty as per AO 2021-0037

A

Stern warning

93
Q

2nd offense penalty as per AO 2021-0037d

A

P30 000

94
Q

3rd offense penalty as per AO 2021-0037

A

P50 000

95
Q

4th offense penalty as per AO 2021-0037

A

Revocation of DOH-LTO

96
Q

If offender is firm or corporation, the ___ shall be liable to the penalty imposed

A

Managing head and/or owner(s)

97
Q

Any person who operates a CL without securing the necessary DOH-PTC and corresponding DOH-LTO shall be issued a ___ and shall pay the administrative penalty of ___

A

Cease-and-desist order (CDO)
P50 000

98
Q

Implementing guideline of RA4688 which provides the guidelines in securing a license to operate a COVID-19 testing laboratory in the Philippines

A

AO 2020-0014

99
Q

Implementing guideline which amends to the AO 2020-0014

A

AO 2020-0014-A

100
Q

Implementing guidelines which amends to the AO 2020-0014-A

A

AO 2020-0014-B

101
Q

Minimum number of personnel in COVID-19 labs

A

7

102
Q

Minimum number of pathologist in COVID-19 labs

A

1

103
Q

Minimum number of analyst in COVID-19 labs

A

3 (3 or 2 MTs & 1 allied health)

104
Q

Minimum number of lab aide in COVID-19 labs

A

1

105
Q

Minimum number of receptionist in COVID-19 labs

A

1

106
Q

Minimum number of encoder in COVID-19 labs

A

1

107
Q

Each personnel in COVID-19 lab must be trained for ___

A

Biosafety and biosecurity
Molecular diagnostic techniques

108
Q

Fit testing or respirator should have ___ efficacy

A

95%

109
Q

Personnel of COVID-19 lab should have annual ___

A

Medical exam w/ influenza vaccination

110
Q

Biosafety cabinet class and type required for specimen preparation

A

Biological safety cabinet class II type A2

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