MODULE 8 - UNIT 3

Question 1

is to ensure utmost safety and quality in the performance of HIV testing by laboratories.

Answer 1

A.O 2005-0026

Question 2

refers to initial serological test performed to determine the
presence of antibody and/or antigen against HIV 1 and HIV 2.

Answer 2

Screening Tests

Question 3

screening tests includes

Answer 3

*Enzyme Immunoassay
* Particle agglutination
* other screening test for HIV antibody

Question 4

refers to the test performance on samplesreactive to the screening test to ensure that the results were true positive.

Answer 4

confirmatory/ supplemental test

Question 5

confirmatory tests includes

Answer 5

western blot
immunofluorescence
radio immuno-precipitation assay
other supplemental tests for HIV antibody

Question 6

NRL for HIV/AIDS testing includes

Answer 6

RITM and SACCL/SLH

Question 7

these laboratories are capable of doing screening and confirmatory laboratory services, training, and surveillance and external quality assurance program for laboratory tests.

Answer 7

RITM & SACCL/SLH

Question 8

the designated NRL for the confirmatory testing of Blood Donors and
Blood Units that tested reactive in the HIV screening test.

Answer 8

RITM

Question 9

the designated NRL for HIV/AIDS, Hepatitis and Sexually
Transmitted Infections.

Answer 9

STD/AIDS COOPERATIVE CENTRAL LAB OF SAN LAZARO HOSPITAL

Question 10

T/F: Only licensed clinical laboratory and/or blood center designated by National
Voluntary Blood Services Program (NVBSP) are allowed to operate an HIV testing
laboratory.

Answer 10

TRUE

Question 11

Only licensed clinical laboratory and/or blood center designated by _____ are allowed to operate an HIV testing
laboratory.

Answer 11

National
Voluntary Blood Services Program (NVBSP)

Question 12

may conduct on site monitoring
visits and shall document the overall quality of the laboratory setting.

Answer 12

Bureau of Health Facilities and Services

Question 13

T/F: HIV testing laboratory should be on section/unit/division of a clinical laboratory or
blood center.

Answer 13

FALSE

Question 14

specific guidelines
1. physical plant:

Answer 14

• well-lighted, ventilated and dust-free
• designated area for pre and post-test counseling
• with adequate water supply

Question 15

specific guidelines
2. Personnel:

Answer 15

Licensed MT with training in HIV Proficiency Testing
certified by NRL-SACCL/SLH

Question 16

use of hiv kits should been registered with

Answer 16

Bureau of Food and Drugs &
valid certificate of product registration

Question 17

report form shall include:

Answer 17

date of specimen received
requesting physician
name & sig of analyst
name & sign of head of the lab
screening assay result

Question 18

shall be referred for confirmatory testing to NRL-SACCL/SLH.

Answer 18

reactive samples

Question 19

submit a ___to the _____

Answer 19

quarterly report & DOH/National Epidemiology Center

Question 20

was defined as an external evaluation of a laboratory’s performance using proficiency panels and assessed by the National Reference Laboratory for HIV/AIDS, Hepatitis and STIs.

Answer 20

EQAS

Question 21

failure to participate in authorized EQAs shall be grounds for

Answer 21

suspension
non-renewal
revocation of HIV accreditation of the lab

Question 22

proficiency training shall be conducted in a maximum of how many days

Answer 22

7 days

Question 23

registration of HIV testing lab, application shall submit:

Answer 23

• intention letter to provide HIV testing services
• list of personnel
• list of equipment w/ specifications
• current certificate of EQAS participation

Question 24

BHFS includes in the LOT of the CL/BC that performance of HIV
testing is among its service capability (approved or not)

Answer 24

approved

Question 25

BHFS sends the findings and recommendation to the applicant
for compliance (approved or not)

Answer 25

disapproved

Question 26

If BHFS fails to process applications within ____ days after its official receipt, it shallbe considered approved.

Answer 26

60