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Medical Technology Laws and Bioethics > Clinical Laboratory Law > Flashcards

Clinical Laboratory Law Flashcards

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USMLE® Step 1 flashcards
1
Q

An act regulating the operation and maintenance of the clinical laboratories and 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 Act of 1966)

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2
Q

Year and date when the Clinical Laboratory Law (RA 4688) was passed by the 6th Congress of the Philippines with valuable contributions extended by the Society in defining the role of the profession and scope of practice of pathology in the country.

A

June 18, 1966

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3
Q

Rules and regulations governing affiliation of medical technology schools, colleges and universities in government hospitals under the department of health.

A

A.O. No. 274
s.1976

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4
Q

Rules and regulations for the accreditation of training laboratories for medical technology interns

A

A.O. No. 21
s.1979

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5
Q

Rules and regulations governing the accreditation of clinical laboratories for training of medical technology interns.

A

A.O. No. 118 – B
s. 1992

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6
Q

Revised fees for laboratory diagnostic procedures performed in the Bureau of Research Laboratories

A

A.O. No. 14 – A
s.1997

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7
Q

The national policy on cytoscreening in cervical cancer control program, in particular designation of medical technologist as cytoscreeners.

A

A.O. No. 19A
s.1998

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8
Q

Decentralization of some regulatory functions of the Bureau of Health facilities and services on clinical laboratories and HIV testing laboratories to the centers for health development in the transition phase

A

A.O. No. 7 – C
s. 2001

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9
Q
  • Rules and regulations governing the
    establishment, operation and
    maintenance of clinical
    laboratories in the Philippines.
  • Important to medtechs/medical
    technologists
  • November 19, 2001
A

A.O. No. 59
s. 2001

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10
Q

Classification of Laboratories

based on A.O. No. 59 s. 2001

A
  • By Function
  • By Institutional Character
  • By Service Capability
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11
Q

the 2 classifications of clinical laboratory by function

A
  • clinical pathology
  • anatomic: pathology
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12
Q

the 2 classifications of clinical laboratory by Institutional Character

A
  • Hospital based laboratory
  • Non-hospital based
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13
Q

the 3 classifications of clinical laboratory by Service Capability

A
  • Primary
  • Secondary
  • Tertiary
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14
Q

what classification of clinical laboratory by function

  • Hematology
  • Immunology and Serology
  • Clinical Chemistry
  • Immunohematology
  • Microbiology
  • Blood banking
  • Parasitology
  • Laboratory endocrinology
  • Mycology
  • Toxicology and TDM
  • Clinical Microscopy
  • Other Disciplines
A

Clinical Pathology

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15
Q

what classification of clinical laboratory by function

  • Surgical pathology
  • Autopsy
  • Immunohistopathology
  • Forensic Pathology
  • Cytology
A

Anatomic pathology

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16
Q

what classification of clinical laboratory by service capability

  • Routine Hematology
  • Routine Urinalysis
  • Routine Fecalysis
  • Blood Typing (for hospital based)
  • Quantitative Platelet
  • Determination (for hospital based)
A

primary

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17
Q

what classification of clinical laboratory by service capability

  • Services of Primary Category Laboratory
  • Routine Clinical Chemistry
  • Cross-Matching (for hospital based)
A

secondary

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18
Q

what classification of clinical laboratory by service capability

  • Services of Secondary Category
  • Laboratory
  • Special Chemistry
  • Special Hematology
  • Immunology/Serology
  • Microbiology
A

Tertiary

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19
Q

Establishment of a cervical cancer screening program

A

A.O. No. 2005 –2006

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20
Q

Revised rules and regulations of governing the licensure and regulation of clinical laboratories in the Philippines (August 22, 2007)

A

A.O. No. 2007 – 0027

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21
Q

The Clinical Laboratory shall be managed by a licensed physician certified by the Philippine Board of Pathology

A

Staffing

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22
Q

For hospital–based clinical laboratory, there shall be at least one registered medical technologist per shift to cover the laboratory operation.

A

staffing

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23
Q

Well –ventilated, adequately lighted, clean and safe. With adequate water supply

A

Physical Facilities

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24
Q

Working space shall be sufficient to accommodate its activities and allow for smooth and coordinated work flow

A

Physical facilities

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25
Q

Working space for all categories of clinical laboratories (both hospital and non–hospital based) shall have at least the following measurements:

A

Physical Facilities

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26
Q

space in sq under primary category

A

10 sq.

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27
Q

space in sq under secondary category

A

20 sq.

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28
Q

space in sq under tertiary category

A

60sq.

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29
Q

There shall be provisions for sufficient number and types of appropriate equipment/instruments in order to undertake all the activities and laboratory examinations. This equipment shall comply with safety requirements.

A

Equipment/Instruments

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30
Q

All categories of clinical laboratories shall provide adequate and appropriate glassware, reagents and supplies necessary to undertake the required services.

A

Glasswares/Reagents/Supplies

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31
Q

There shall be provisions for adequate and efficient disposal of waste following guidelines of the Department of Health and the local government.

A

Waste Management

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32
Q

There shall be a documented, continuous competency assessment program for all laboratory personnel.

A

Internal Quality Control Program

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33
Q

A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of license.

A

External Quality Control Program
 All clinical laboratories shall p

34
Q

Laboratory requests shall be constructed as consultation between the requesting physician and the Pathologist of the laboratory and as such laboratory results shall be released accordingly.

A

Reporting

35
Q

No person in the clinical laboratory shall issue a report, orally or in writing, whole or portions, thereof without a directive from the Pathologist or his authorized associate to the requesting physician or his authorized representative except in emergency cases when the results may be released as authorized by the Pathologist

A

Reporting

36
Q

TRUE OR FALSE:  Medical Technician can sign the report (computerized); medical technologist or physician

A

FALSE

37
Q

TRUE OR FALSE:  Medical Technician can sign the report (computerized); medical technologist or physician

A

FALSE

38
Q

All laboratory records shall be kept on file for at least ______ year.

A

1 YEAR

39
Q

The rates shall be ______________________________________ prevailing at the time and the particular place, taking into consideration the cost of testing and quality control of various laboratory procedures.

A

within the range of the usual fees

40
Q

There shall be a system of ______________________ to ensure quality results.

A

accurate recording

41
Q

BHFS

A

Bureau of Health Facilities and Services

42
Q

CHD

A

Center for Health Development

43
Q

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

44
Q

Critical Values

(real value)

A

K+ 3.5-5.2 or 10 mmo/L

45
Q

Critical Values

(real value)

A

K+ 3.5-5.2 or 10 mmo/L

46
Q

EQAP

A

External Quality Assessment
Program

47
Q

It is a program where
participating laboratories are given
unknown samples for analysis.

A

External Quality Assessment
Program

48
Q

The document issued by the DOH
to an individual, agency,
partnership or corporation that
operates a clinical laboratory upon
compliance with the requirements
set forth in this Order.

A

license

49
Q

The individual, agency, partnership
or corporation to whom the license
is issued and upon who rests
compliance with this Order.

A

licensee

50
Q

LTO

A

License to Operate

51
Q

A laboratory testing unit that moves
from testing site to another testing
site or has a temporary testing
location. It shall have a base
laboratory.

A

Mobile Clinical
Laboratory

52
Q

NRL

A

National Reference Laboratory

53
Q

It is a laboratory in a government hospital which has been designated by the DOH to provide special functions and services for specific disease areas.

A

NRL

54
Q

EQAS

A

evaluation of diagnostic
kits and reagents

55
Q

POL

A

Physician’s Office Laboratory

56
Q

It is an individual doctor’s office/clinic wherein laboratory examinations are performed.

A

Physician’s Office Laboratory

57
Q

POCT

A

Point of Care Testing

58
Q

It is a diagnostic testing at or near the site of patient care rather than in the clinical laboratory. It includes bedside testing, outpatient and home care.

A

Point of Care Testing

59
Q

The basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately upon completion. It shall follow the usual procedures and system in the laboratory.

A

Routine Tests

60
Q

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

61
Q

Tests done on urgent cases, the results of which shall be released immediately, within one (1) hour after the procedure. STAT is an
abbreviation “sta’tim” which means immediately.

A

STAT Tests

62
Q

Enforceable order issued by a public authority to an individual or an organization to force certain connective action or to refrain from an activity.

A

A.O (Administrative Order)

63
Q

Medical specialty that is concerned with the diagnosis of disease based on the laboratory analysis of body fluids such as blood and urine.

A

clinica pathology

64
Q

Test of organs and tissue of a living/dead body

A

anatomic pathology

65
Q

Died because of murder or crimes

A

NBI

66
Q

Died because of disease

A

Died because of disease

67
Q

morning shift

A

6am-2pm

68
Q

PM shift

A

2-10pm

69
Q

night shift

A

10pm-6am

70
Q

NRL for Dengue, Influenza, Tuberculosis and other Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, Measles and other Viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases;

National Reference Laboratories

A

Research Institute for Tropical Medicine (RITM)

71
Q

NRL for confirmatory testing of blood units

A

Research Institute for Tropical Medicine (RITM)

72
Q

NRL for HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STls)

A

San Lazaro Hospital (SLH)

73
Q

NRL for Environmental and Occupational Health; Toxicology and Micronutrient Assay

A

East Avenue Medical Center
(EAMC)

74
Q

NRL for Hematology including Immunohematology, Immunopathology and Anatomic Pathology

A

National Kidney and Transplant Institute (NKTI)

75
Q

NRL for Biochemistry

A

Lung Center of the Philippines

76
Q

laboratory that offers highly specialized tests that are usually not provided with a general clinical laboratory.

A

SPECIAL LABORATORY

77
Q
  • Routine Hematology
  •  Qualitative Platelet Det.
  •  Routine UA/ FA
  •  Blood typing (hospital based)

this falls under what category (service capability)

A

primary category

78
Q
  • Services of the Primary Category
  •  Routine CC
  •  Quantitative Platelet Det.
  •  Cross Matching (hospital based)
  •  Gram Staining (hospital based)
  •  KOH (hospital based)

this falls under what category (service capability)

A

Secondary Category

79
Q
  • Services of the Secondary Laboratory
  •  Special CC
  •  Special Hematology (Inc. Coagulation procedures)
  •  Immunology
  •  Microbio (C/S) Culture and Sensitivity
A

Tertiary Category

80
Q

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

A

Limited Service Laboratory (for institution-based
only)

81
Q

Any person who operates a clinical laboratory without proper license from the DOH shall upon conviction be subject to imprisonment for ________________ or both at the discretion of the court. Provided, however, that if the offender is a firm or a corporation, the managing head and/or the owner(s) shall be liable to penalty
imposed

A

not less than one (1) month or a fine not less than Php 1,000 and not more than Php 5,000

Medical Technology Laws and Bioethics (9 decks)

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