Clinical Laboratory Law

Question 1

Clinical Laboratory Law of 1966

Answer 1

RA 4688

Question 2

when was RA 4688 approved?

Answer 2

June 18, 1966

Question 3

BRL

Answer 3

Bureau of Research and Laboratories

Question 4

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

Answer 4

RA 4688

Question 5

operated and maintained partially of wholly by the national government

Answer 5

Government Clinical Laboratory

Question 6

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

Answer 6

Private Clinical Laboratory

Question 7

offer basic and routine laboratory examinations

Answer 7

General Clinical Laboratories

Question 8

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

Answer 8

Limited Service Capability

Question 9

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

Answer 9

Special Clinical Laboratories

Question 10

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

Answer 10

License To Operate (LTO)

Question 11

How long is the validity of the LTO?

Answer 11

1 year

Question 12

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

Answer 12

Physician’s Office Laboratory

Question 13

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

Answer 13

Mobile Clinical Laboratory

Question 14

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

Answer 14

100-kilometer radius from its main lab

Question 15

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

Answer 15

Point Of Care Testing

Question 16

estimated time of processing of a single lab test

Answer 16

10 mins

Question 17

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

Answer 17

National Reference Laboratory

Question 18

EQAP

Answer 18

External Quality Assessment Program

Question 19

EQAS

Answer 19

External Quality Assessment Survey

Question 20

how many days can a complain be appealed?

Answer 20

10 calendar days

Question 21

BHFS

Answer 21

Bureau of Health Facilities and Services

Question 22

CHD

Answer 22

Center for Health Development

Question 23

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

Answer 23

applicant

Question 24

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

Answer 24

applicant

Question 25

panic values originally described by Lundberg as "life-threatening"

Answer 25

critical values

Question 26

a program where participating laboratories are given unknown samples

Answer 26

EQAP

Question 27

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

Answer 27

inspection tool

Question 28

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

Answer 28

Institution

Question 29

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

Answer 29

Licensee

Question 30

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

Answer 30

monitoring examinations

Question 31

the basic, commonly requested tests in the laboratory

Answer 31

routine tests

Question 32

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

Answer 32

satellite testing site

Question 33

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

Answer 33

STAT test

Question 34

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

Answer 34

1

Question 35

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

Answer 35

yes