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Laboratory Management > CLINICAL LABORATORY AND ITS ORGANIZATIONAL STRUCTURE (APPLICATION, LICENSING, RENEWAL AND INSPECTION) > Flashcards

CLINICAL LABORATORY AND ITS ORGANIZATIONAL STRUCTURE (APPLICATION, LICENSING, RENEWAL AND INSPECTION) Flashcards

1
Q

An Act Regulating the Operation and Maintenance of Clinical Laboratories
and requiring the registration of the same with the Department of Health,
providing penalty for the violation.

A

REPUBLIC ACT NO. 4688

CLINICAL LABORATORY ACT OF 1966

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2
Q

What is R.A 4688

A

CLINICAL LABORATORY ACT OF 1966

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3
Q

What is the date of approval of the REPUBLIC ACT NO. 4688

A

Approved on June 18, 1966

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4
Q

IMPLEMENTING RULES AND REGULATIONS (DOH):
Rules and Regulations Governing the
Establishment, Operation and Maintenance of
Clinical Laboratories in the Philippines

A

A.O.

59-2001

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5
Q

IMPLEMENTING RULES AND REGULATIONS (DOH):
Revised Rules and Regulations Governing the
Licensure and Regulation of Clinical Laboratories
in the Philippines

A

A.O.

27-2007

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6
Q

Institution based laboratory is owned by the ___

A

Government

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7
Q

Free Standing laboratory is owned by the ___

A

Private Institution

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8
Q

The function of the Government Laboratory

A

Clinical

Pathology

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9
Q

The function of the Private owned laboratory

A

Anatomic

Pathology

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10
Q

Service Capability of a Government owned laboratory

A

General

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11
Q

Service Capability of a Private owned laboratory

A

Special

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12
Q

What type of pathology handles:

•Clinical Chemistry

A

CLINICAL PATHOLOGY

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13
Q

What type of pathology handles:

•Hematology

A

CLINICAL PATHOLOGY

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14
Q

What type of pathology handles:

•Immunohematology (Blood Banking)

A

CLINICAL PATHOLOGY

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15
Q

What type of pathology handles:

•Microbiology

A

CLINICAL PATHOLOGY

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16
Q

What type of pathology handles:

•Immunology and Serology

A

CLINICAL PATHOLOGY

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17
Q

What type of pathology handles:

•Clinical Microscopy

A

CLINICAL PATHOLOGY

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18
Q

What type of pathology handles:

• Endocrinology

A

CLINICAL PATHOLOGY

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19
Q

What type of pathology handles:

•Molecular Biology

A

CLINICAL PATHOLOGY

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20
Q

What type of pathology handles:

•Cytogenetics

A

CLINICAL PATHOLOGY

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21
Q

What type of pathology handles:

• Toxicology

A

CLINICAL PATHOLOGY

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22
Q

What type of pathology handles:

• Therapeutic Drug Monitoring

A

CLINICAL PATHOLOGY

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23
Q

What type of pathology handles:

•Surgical Pathology

A

ANATOMIC PATHOLOGY

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24
Q

What type of pathology handles:

•Immunohistopathology

A

ANATOMIC PATHOLOGY

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25
Q

What type of pathology handles:

•Cytology

A

ANATOMIC PATHOLOGY

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26
Q

What type of pathology handles:

•Autopsy

A

ANATOMIC PATHOLOGY

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27
Q

What type of pathology handles:

•Forensic Pathology

A

ANATOMIC PATHOLOGY

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28
Q

What type of pathology handles:

•Molecular Pathology

A

ANATOMIC PATHOLOGY

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29
Q

What type of general clinical laboratory handles:

▪Routine Hematology

A

Primary

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30
Q

What type of general clinical laboratory handles:
▪All the services provided by
the PRIMARY CLINICAL
LABORATORY

A

Secondary

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31
Q

▪All the services provided by
the SECONDARY
CLINICAL LABORATORY

A

Tertiary

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32
Q 
▪ Provides particular service 
only IN AN INSTITUTION
Example:
- Dialysis Centers
- Social Hygiene clinics
A

Limited Services

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33
Q

What type of general clinical laboratory handles:

▪Routine Urinalysis

A

Primary

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34
Q

What type of general clinical laboratory handles:

▪Routine Fecalysis

A

Primary

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35
Q

What type of general clinical laboratory handles:
▪Blood typing
(hospital-based)

36
Q

What type of general clinical laboratory handles:
▪Qualitative Platelet
Count

37
Q

What type of general clinical laboratory handles:

▪Routine Clinical Chemistry

38
Q

What type of general clinical laboratory handles:

• Fasting Blood Sugar (FBS)

39
Q

What type of general clinical laboratory handles:
•Kidney Function test (Urea,
Creatinine & Uric Acid)

40
Q

What type of general clinical laboratory handles:

▪ Quantitative Plate count

41
Q

What type of general clinical laboratory handles:
▪Crossmatching
(hospital-based)

42
Q

What type of general clinical laboratory handles:

▪KOH (hospital-based)

43
Q

What type of general clinical laboratory handles:
▪Gram staining
(hospital-based)

44
Q

What type of general clinical laboratory handles:

Special Chemistry

45
Q

What type of general clinical laboratory handles:

▪ Special Hematology

46
Q

What type of general clinical laboratory handles:

▪Immunology

47
Q

What type of general clinical laboratory handles:

▪Culture and Sensitivity

48
Q

What type of general clinical laboratory handles:
•Aerobic and Anaerobic
(hospital-based)

49
Q

What type of general clinical laboratory handles:
•Aerobic or Anaerobic (non
hospital-based)

50
Q

Offers Highly Specialized Services like:

a) Genetics laboratory
b) DNA
c) Molecular Biology laboratory

51
Q

No need to secure License to Operate (LTO) otherwise stipulated by
the law.

52
Q

Only __________R.A. 7719 has license

A

Immunohematology (Blood Banking)

53
Q

______ supervises the clinical laboratory; in absence any physician
trained and authorized by _____

A

Pathologist, DOH

54
Q

Must be a graduate of medicine

A

Pathologist

55
Q

Residency for Pathology Laboratory:

Clinical Pathology

56
Q

Residency for Pathology Laboratory:

Anatomic Pathology

57
Q

Residency for Pathology Laboratory:

Forensic Pathology

A

In camp crame

58
Q

The pathologist must pass the ____(both written and practical)

A

Board of Pathology Exam

59
Q

Three (3) month training by the DOH regarding:

A
  1. Laboratory management
  2. Quality Assurance (QA)
  3. Quality Control (QC)
60
Q

Pathologist:
___in any category, or
3 ______ and 1 ______

A

4 clinical laboratories, 3 clinical laboratories and 1 blood bank

61
Q

Physician:

_______either primary or secondary

A

1 clinical laboratory

62
Q

They give out license to operate

A

•Department of Health – Bureau of Health Facilities & Services
(DOH-BHFS)

63
Q

what is the meaning of

64
Q

LTO is valid to for how many year/s?

65
Q

EXEMPTIONS IN SECURING LICENSE TO
OPERATE FROM BHFS:
Laboratories operated and maintained exclusively for ______ and
_______ purposes

A

research and teaching

66
Q

EXEMPTIONS IN SECURING LICENSE TO
OPERATE FROM BHFS:
Special clinical laboratories operating _______ of clinical
laboratories

A

independently

67
Q

EXEMPTIONS IN SECURING LICENSE TO
OPERATE FROM BHFS:
______ office Laboratory

A

Physician’s

68
Q

All government laboratories are exempted in LTO when they are performing microscopy works for______,_______ and __________

A

a. Malarial screening
b. Acid-Fast Bacteria (AFB) Screening
c. STD screening

69
Q

CONSIDERATIONS IN LTO ISSUANCE:

Clinical Laboratory and its satellite in the ___________

A

same compound

70
Q

CONSIDERATIONS IN LTO ISSUANCE:

Satellite laboratory ________ the premises of central laboratory

71
Q

CONSIDERATIONS IN LTO ISSUANCE:

__________ laboratory

72
Q

where should they renew the LTO

A

regional in Center for Health Development (CHD) or in the DOH-BHFS

73
Q

May start to renew their license in ____ days before expiration (last day of the year – December
31)

74
Q

What are the inspection done by the DOH-BHFS in the laboratory

A

Quality Assurance Programs
✔ Internal Quality Control Program
✔ Internal Quality Assurance Program
✔ Continuous Quality Improvement Program
✔ External Quality Assurance Program (EQAP) by NRL – National Reference
Laboratory
✔ International External Quality Assurance Program (EQAP) by The Joint
Commission (TJC) and College of American Pathologist (CAP)

75
Q

what type of National Reference Laboratory does:

Bacteriology

A

Research Institute for Tropical

Medicine (RITM)

76
Q

what type of National Reference Laboratory does:

Parasitology

A

Research Institute for Tropical

Medicine (RITM)

77
Q

what type of National Reference Laboratory does:

Mycobacteriology

A

Research Institute for Tropical

Medicine (RITM)

78
Q

what type of National Reference Laboratory does:

Transfusion Transmitted Infection (TTI)

A

Research Institute for Tropical

Medicine (RITM)

79
Q

what type of National Reference Laboratory does:

Hematology

A

National Kidney and Transplant

Institute (NKTI)

80
Q

what type of National Reference Laboratory does:

Clinical Chemistry

A

Lung Center of the Philippines

LCP

81
Q

what type of National Reference Laboratory does:

Drug Test

A

EAST AVENUE MEDICAL

CENTER

82
Q

what type of National Reference Laboratory does:

Water Bacteriology

A

EAST AVENUE MEDICAL

CENTER

83
Q

what type of National Reference Laboratory does:

HIV testing

A

STD AIDS Cooperative Central
Laboratory – San Lazaro
Hospital (SACCL-SLH)

84
Q

what type of National Reference Laboratory does:

HBV testing

A

STD AIDS Cooperative Central
Laboratory – San Lazaro
Hospital (SACCL-SLH)

85
Q

what type of National Reference Laboratory does:

HCV testing

A

STD AIDS Cooperative Central
Laboratory – San Lazaro
Hospital (SACCL-SLH)

86
Q

what type of National Reference Laboratory does:

Syphilis testing

A

STD AIDS Cooperative Central
Laboratory – San Lazaro
Hospital (SACCL-SLH)

Laboratory Management (2 decks)

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