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Clinical Laboratory Law Flashcards

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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
Working space for all categories of clinical laboratories (both hospital and non–hospital based) shall have at least the following measurements:
Physical Facilities
26
space in sq under primary category
10 sq.
27
space in sq under secondary category
20 sq.
28
space in sq under tertiary category
60sq.
29
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.
Equipment/Instruments
30
All categories of clinical laboratories shall provide adequate and appropriate glassware, reagents and supplies necessary to undertake the required services.
Glasswares/Reagents/Supplies
31
There shall be provisions for adequate and efficient disposal of waste following guidelines of the Department of Health and the local government.
Waste Management
32
There shall be a documented, continuous competency assessment program for all laboratory personnel.
Internal Quality Control Program
33
A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of license.
External Quality Control Program  All clinical laboratories shall p
34
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.
Reporting
35
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
Reporting
36
TRUE OR FALSE:  Medical Technician can sign the report (computerized); medical technologist or physician
FALSE
37
TRUE OR FALSE:  Medical Technician can sign the report (computerized); medical technologist or physician
FALSE
38
All laboratory records shall be kept on file for at least ______ year.
1 YEAR
39
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.
within the range of the usual fees
40
There shall be a system of ______________________ to ensure quality results.
accurate recording
41
BHFS
Bureau of Health Facilities and Services
42
CHD
Center for Health Development
43
Panic values originally described by Lundberg as “life – threatening” unless something is done promptly and for which some corrective action could be undertaken.
Critical Values
44
Critical Values | (real value)
K+ 3.5-5.2 or 10 mmo/L
45
Critical Values | (real value)
K+ 3.5-5.2 or 10 mmo/L
46
EQAP
External Quality Assessment Program
47
It is a program where participating laboratories are given unknown samples for analysis.
External Quality Assessment Program
48
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.
license
49
The individual, agency, partnership or corporation to whom the license is issued and upon who rests compliance with this Order.
licensee
50
LTO
License to Operate
51
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.
Mobile Clinical Laboratory
52
NRL
National Reference Laboratory
53
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.
NRL
54
EQAS
evaluation of diagnostic kits and reagents
55
POL
Physician’s Office Laboratory
56
It is an individual doctor’s office/clinic wherein laboratory examinations are performed.
Physician’s Office Laboratory
57
POCT
Point of Care Testing
58
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.
Point of Care Testing
59
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.
Routine Tests
60
Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory but performed outside the physical confines of that laboratory.
Satellite Testing Site
61
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.
STAT Tests
62
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.O (Administrative Order)
63
Medical specialty that is concerned with the diagnosis of disease based on the laboratory analysis of body fluids such as blood and urine.
clinica pathology
64
Test of organs and tissue of a living/dead body
anatomic pathology
65
Died because of murder or crimes
NBI
66
Died because of disease
Died because of disease
67
morning shift
6am-2pm
68
PM shift
2-10pm
69
night shift
10pm-6am
70
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
Research Institute for Tropical Medicine (RITM)
71
NRL for confirmatory testing of blood units
Research Institute for Tropical Medicine (RITM)
72
NRL for HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STls)
San Lazaro Hospital (SLH)
73
NRL for Environmental and Occupational Health; Toxicology and Micronutrient Assay
East Avenue Medical Center (EAMC)
74
NRL for Hematology including Immunohematology, Immunopathology and Anatomic Pathology
National Kidney and Transplant Institute (NKTI)
75
NRL for Biochemistry
Lung Center of the Philippines
76
laboratory that offers highly specialized tests that are usually not provided with a general clinical laboratory.
SPECIAL LABORATORY
77
* Routine Hematology *  Qualitative Platelet Det. *  Routine UA/ FA *  Blood typing (hospital based) | this falls under what category (service capability)
primary category
78
* 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)
Secondary Category
79
* Services of the Secondary Laboratory *  Special CC *  Special Hematology (Inc. Coagulation procedures) *  Immunology *  Microbio (C/S) Culture and Sensitivity
Tertiary Category
80
Provides laboratory tests required for a particular service in an institution such as, but not limited to, dialysis centers and social hygiene clinics
Limited Service Laboratory (for institution-based only)
81
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
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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