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Medtech Laws and Bioethics > Clinical Laboratory Law > Flashcards

Clinical Laboratory Law Flashcards

1
Q

Clinical Laboratory Law of 1966

A

RA 4688

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2
Q

when was RA 4688 approved?

A

June 18, 1966

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3
Q

BRL

A

Bureau of Research and Laboratories

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4
Q

the law regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the DOH, through th HFSRB

A

RA 4688

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5
Q

operated and maintained partially of wholly by the national government

A

Government Clinical Laboratory

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6
Q

owned, established, and operated by an individual, corporation, association or organization

A

Private Clinical Laboratory

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7
Q

offer basic and routine laboratory examinations

A

General Clinical Laboratories

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8
Q

provide 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

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9
Q

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

A

Special Clinical Laboratories

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10
Q

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

A

License To Operate (LTO)

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11
Q

How long is the validity of the LTO?

A

1 year

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12
Q

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

A

Physician’s Office Laboratory

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13
Q

a specialized facility that moves from one testing site to another or has a temporary testing location

A

Mobile Clinical Laboratory

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14
Q

mobile clinical lab is only allowed to operate within this kilometer radius

A

100-kilometer radius from its main lab

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15
Q

a diagnostic test at or near the site of patient care rather than in the clinical laboratory

A

Point Of Care Testing

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16
Q

estimated time of processing of a single lab test

A

10 mins

17
Q

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

A

National Reference Laboratory

18
Q

EQAP

A

External Quality Assessment Program

19
Q

EQAS

A

External Quality Assessment Survey

20
Q

how many days can a complain be appealed?

A

10 calendar days

21
Q

BHFS

A

Bureau of Health Facilities and Services

22
Q

CHD

A

Center for Health Development

23
Q

a natural or judicial person who intends to operate a clinical laboratory

A

applicant

24
Q

a natural or judicial person who intends to operate a clinical laboratory

A

applicant

25
Q

panic values originally described by Lundberg as “life-threatening”

A

critical values

26
Q

a program where participating laboratories are given unknown samples

A

EQAP

27
Q

the checklist used by the regulatory officers during inspection visit to evaluate compliance of a clinical laboratory to the minimum standards and technical requirements

A

inspection tool

28
Q

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

A

Institution

29
Q

the individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance with this order

A

Licensee

30
Q

tests done in series on patients a guide for treatment or follow-up of their condition

A

monitoring examinations

31
Q

the basic, commonly requested tests in the laboratory

A

routine tests

32
Q

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

A

satellite testing site

33
Q

tests done on urgent cases, result should be released in an hour

A

STAT test

34
Q

how many license to operate shall a clinical lab and its satellite services within the same compound have?

A

1

35
Q

does a satellite lab outside the premises where the central lab is located need a separate LTO?

A

yes

Medtech Laws and Bioethics (4 decks)

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