MODULE 4

Question 1

RA 4688 and date of approval

Answer 1

Clinical Laboratory Law

May 19, 1996

Question 2

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

Answer 2

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

Question 3

An act regulating the operation and maintenance of Clinical Laboratories

Answer 3

RA 4688 (Clinical Laboratory Law)

Question 4

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

Answer 4

DOH A.O 2021-0037

Question 5

when was DOH A.O 2021-0037 published?

Answer 5

June 11, 2021

Question 6

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

Answer 6

CLINICAL LABORATORY

Question 7

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

Answer 7

clinical laboratory

Question 8

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

Answer 8

CLINICAL PATHOLOGY

Question 9

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

Answer 9

Government

Question 10

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

Answer 10

ANATOMIC PATHOLOGY

Question 11

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

Answer 11

MOLECULAR PATHOLOGY

Question 12

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

Answer 12

true

Question 13

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

Answer 13

non-institution based

Question 14

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

Answer 14

SATELLITE CLINICAL LABORATORY

Question 15

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

Answer 15

MOBILE CLINICAL LABORATORY

Question 16

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

Answer 16

false, all CL are required to secure DOH-LTO

Question 17

validity of DOH-LTO

Answer 17

1 year only

Question 18

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

Answer 18

100 kilometers

Question 19

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

Answer 19

true

Question 20

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

Answer 20

true

Question 21

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

Answer 21

DOH-HFSRB

the CL must register for DOH-HFSRB

Question 22

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

Answer 22

NRL (National Reference Laboratory)

Question 23

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

Answer 23

NRL (National Reference Laboratory)

Question 24

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

Answer 24

NEQAS

National External Quality Assessment Scheme

Question 25

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

Answer 25

Physician's Office Laboratory (POL)

Question 26

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

Answer 26

true | pg 11 of Module 4

Question 27

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

Answer 27

Point of Care Testing (PCOT)

Question 28

who is designated as the POCT coordinator?

Answer 28

the senior staff

Question 29

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

Answer 29

false it must be FDA-approved

Question 30

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

Answer 30

STAT tests

Question 31

how many hours must STAT tests release

Answer 31

within 1 hr only

Question 32

refers to panic values originally described as "life-threatening"

Answer 32

CRITICAL VALUES

Question 33

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

Answer 33

true

Question 34

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

Answer 34

REFERRAL TESTS

Question 35

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

Answer 35

DOH-PTC Department of Health - Permit to Construct

Question 36

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

Answer 36

true

Question 37

how many days can the laboratory comply with the deficiencies?

Answer 37

within 30 days

Question 38

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

Answer 38

the application will be denied

Question 39

DOH-LTO is transferable --> true or false

Answer 39

FALSE it is non-transferable

Question 40

what is COR required for

Answer 40

for RESEARCH and teaching laboratories

Question 41

validity of DOH-LTO

Answer 41

1 YEAR

Question 42

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

Answer 42

3 years

Question 43

who prescribes all the fees

Answer 43

DOH

Question 44

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

Answer 44

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

Question 45

Who is responsible for the penalization of a CL

Answer 45

HFSRB / CHED Director

Question 46

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

Answer 46

3 years