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MTLBE > MODULE 4 > Flashcards

MODULE 4 Flashcards

1
Q

RA 4688 and date of approval

A

Clinical Laboratory Law

May 19, 1996

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2
Q

a head of a registered clinical laboratory must be a……….

A

licensed physician duly qualified in laboratory medicine and authorized by the secretary of health

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3
Q

An act regulating the operation and maintenance of Clinical Laboratories

A

RA 4688 (Clinical Laboratory Law)

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4
Q

known as the New rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

A

DOH A.O 2021-0037

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5
Q

when was DOH A.O 2021-0037 published?

A

June 11, 2021

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6
Q

A facility that is involved in the preanalytical, analytical, and post-analytical procedures

A

CLINICAL LABORATORY

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7
Q

a facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases

A

clinical laboratory

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8
Q

A classification by function of CL wherein it deals with the chemical and cellular analyses of blood and other body fluids

A

CLINICAL PATHOLOGY

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9
Q

classification of ownership of CL wherein it is operated and maintained, partially or wholly, by the national government

A

Government

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10
Q

A classification by function of CL wherein it provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues

A

ANATOMIC PATHOLOGY

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11
Q

A classification by function of CL wherein it deals with the analysis of certain genes, proteins, and other molecules from organs, tissues or bodily fluids

A

MOLECULAR PATHOLOGY

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12
Q

Institution-based laboratories are laboratories located within the premises and operates as part of a DOH licensed health facility —> true or false

A

true

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13
Q

classification by institutional character by CL wherein it operates independently and is not attached to any DOH licensed health facility

A

non-institution based

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14
Q

refers to an extension of the main CL located within the facility’s compound or premises

A

SATELLITE CLINICAL LABORATORY

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15
Q

a lab testing unit that is capable of performing limited CL diagnostic procedures. it also moves from one testing site to another

A

MOBILE CLINICAL LABORATORY

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16
Q

all CL are not required to secure DOH-LTO from DOH regulatory office –> true or false

A

false, all CL are required to secure DOH-LTO

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17
Q

validity of DOH-LTO

A

1 year only

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18
Q

the mobile CL must be at a maximum of _______ kilometers from the main laboratory

A

100 kilometers

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19
Q

the main laboratory must be a DOH licensed laboratory –> true or false

A

true

20
Q

the DOH-licensed CL shall not perform any examinations or testing beyond its authorised service capability –> true or false

A

true

21
Q

what is required for CL who operates exclusively for research and teaching purposes?

A

DOH-HFSRB

the CL must register for DOH-HFSRB

22
Q

the highest level of laboratory in the Philippines performing highly complex procedures, including confirmatory testing

A

NRL (National Reference Laboratory)

23
Q

the highest level of laboratory that is responsible for facilitation NEQAS to ensure standards for regulation and licensing of all laboratories in the Philippines

A

NRL (National Reference Laboratory)

24
Q

an EQAP activity conducted by NRL to assess the quality of performance and accuracy of the results of laboratories

A

NEQAS

National External Quality Assessment Scheme

25
Q

refers to the doctor’s office/clinic wherein CL examinations are performed for purpose of monitoring the doctor’s patients only

A

Physician’s Office Laboratory (POL)

26
Q

POL who is not within the premises of a DOH-regulated facility shall not be under the supervision of the CL –> true or false

A

true

pg 11 of Module 4

27
Q

refers to diagnostic testing done at or near the site of patient care rather than in the CL

A

Point of Care Testing (PCOT)

28
Q

who is designated as the POCT coordinator?

A

the senior staff

29
Q

the reagents and test-kits must be DOH-approved –> true or false

A

false

it must be FDA-approved

30
Q

type of tests that are done on urgent cased, the result of which shall be released immediately

A

STAT tests

31
Q

how many hours must STAT tests release

A

within 1 hr only

32
Q

refers to panic values originally described as “life-threatening”

A

CRITICAL VALUES

33
Q

all lab reports must have the name of the RMT –> true or false

A

true

34
Q

refers to CL tests that are either sent out or outsourced to other DOH-licensed CL with the same or higher service capability

A

REFERRAL TESTS

35
Q

refers to the permit issued by the DOH through HFSRB or CHD-HFSRB to an applicant who will establish or operate a hospital or other health facility

A

DOH-PTC

Department of Health - Permit to Construct

36
Q

DOH-PTC are only for new, renovated, change in ownership and transfer of location —> true or false

A

true

37
Q

how many days can the laboratory comply with the deficiencies?

A

within 30 days

38
Q

if the laboratory was not able to comply with the deficiencies for 30 days, what will happen?

A

the application will be denied

39
Q

DOH-LTO is transferable –> true or false

A

FALSE

it is non-transferable

40
Q

what is COR required for

A

for RESEARCH and teaching laboratories

41
Q

validity of DOH-LTO

A

1 YEAR

42
Q

COR for CL shall be required to register with the DOH-HFSRB every

A

3 years

43
Q

who prescribes all the fees

A

DOH

44
Q

CL that is operated and maintained exclusively for research and teaching purposes shall issue official results for diagnostic purposes. –> true or false

A

false

they cannot issue official results for diagnostic purposes because it is beyond of their capabilities

45
Q

Who is responsible for the penalization of a CL

A

HFSRB / CHED Director

46
Q

what is the validity of CL that is operated and maintained exclusively for research and teaching purposes?

A

3 years

MTLBE (6 decks)

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