REGULATION OF THE CLINICAL LABORATORIES

Question 1

The ____________________, through the ______________________________ shall exercise regulatory functions under the rules and regulations of the Act.

Answer 1

Department of Health (DOH); Bureau of Health Facilities and Services (BHFS)

Question 2

LICENSE TO OPERATE (LTO)
Validity:

Answer 2

1 year validity

Question 3

LICENSE TO OPERATE (LTO)
Application:

Answer 3

thru DOH or Online Licensing Regulatory Systems (OLRS)

Question 4

must be displayed in the laboratory at all times

Answer 4

LICENSE TO OPERATE (LTO)

Question 5

If the applying laboratory is not fully compliant with the requirements, the laboratory shall be given ___ days to comply

Answer 5

30

Question 6

Submitted complete applications that are not processed within ___ days by the _________________________, in accordance with the current ____ guidelines, due to force majeure, shall automatically be granted the ____, and a post-licensing visit shall be scheduled.

Answer 6

20; HFSRB (BHFS) /CHD-RLED; DOH; LTO

Question 7

only those with certification by DOH are allowed to secure a LTO as Rapid HIV Diagnostic Algorithm (rHIVda) Confirmatory Laboratory

Answer 7

A.O. 37 s 2021 addition

Question 8

old confirmatory for HIV

Answer 8

Western blot

Question 9

new confirmatory as it is more cost effective (3 rapid kits)

Answer 9

rHIVda

Question 10

HIV confirmatory is now decentralized thru rHIVda allowing _______ to confirm

Answer 10

non-NRL

Question 11

Only DOH licensed CL identified by the program and has already secured a certificate of “________________________” from the DOH or its designated regional counterpart, shall be allowed to apply for a license from CrCL

Answer 11

Certified rHIVda Confirmatory Laboratory