Decision No. 12/2005/QD-BYT on issuing the "Regulations on Professional Aspects of HIV Screening Tests to Ensure Blood Safety"

Pursuant to …;

Regarding the issuance of "Professional Regulations for HIV Testing to Ensure Blood Safety" HIV testing to ensure blood safety

THE MINISTER OF HEALTH

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Ordinance on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS) dated May 31, 1995;

Pursuant to Decree No. 34/CP dated June 1, 1996 of the Government guiding the implementation of the Ordinance on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS);

At the proposal of the Director of the Preventive Medicine and HIV/AIDS Control Department and the Director of the Treatment Department of the Ministry of Health,

DECISION:

Article 1. Issued herewith are the "Professional Regulations for HIV Testing to Ensure Blood Safety."

Article 2. These regulations apply to state-owned, private, and public health facilities.

Article 3. These regulations shall take effect fifteen days from the date of publication in the Official Gazette and shall supersede Decision No. 175/2001/QĐ-BYT dated January 18, 2001 of the Minister of Health regarding "Professional Regulations for Blood Testing to Prevent HIV/AIDS Transmission."

Article 4. The Permanent Secretaries, Inspectors, Heads of Departments, Directors of Provincial Health Services under central cities, Heads of units under the Ministry of Health, and Heads of health services in sectors are responsible for implementing these regulations.

PROFESSIONAL REGULATIONS FOR HIV TESTING TO ENSURE BLOOD SAFETY

(Issued together with Decision No. 12/2005/QĐ-BYT dated March 28, 2005)

I. GENERAL PROVISIONS:

of the Minister of Health)

1. These regulations guide the screening of HIV testing for blood transfusion, blood product transfusion, and the implementation of assisted reproductive techniques and organ transplantation at state-owned, private, and public health facilities (hereinafter referred to as health facilities).

2. HIV screening tests must comply with professional technical regulations issued by the Ministry of Health.

II. SPECIFIC PROVISIONS:

1. Provisions on HIV screening tests:

a) Health facilities are required to conduct HIV screening tests on:

- Blood bags before transfusion (including emergency cases) or for blood product preparation.

- Donors of sperm, ova, tissue, or human organs.

b) HIV screening tests must be conducted using diagnostic HIV reagents that have been certified for circulation in Vietnam by the Ministry of Health.

2. Provisions on recording, storing, and reporting HIV test results:

a) All HIV test results must be fully recorded in the donor's medical file, blood component file, sperm, ova, tissue, or organ file, as well as in the laboratory's test result logbook.

b) The test result logbook must include the following information:

- Date, month, year of the test.

- Name, age, gender, address of the blood donor, blood component, tissue, or organ donor. If it is a blood donor, the blood group must also be included. For sperm and ova donors, this section is not necessarily required but the HIV test sample code must match the storage code of the sperm or ova.

- Test result: If positive for HIV, it must be clearly stated as "positive," and if negative, as "negative."

- Type of diagnostic reagent and testing technique.

- Name of the physician or technician conducting the test.

c) Reporting HIV test results to blood donors, blood components, sperm, ova, tissue, or organ donors must follow the provisions set out in Item 4 of Directive No. 11/2001/CT-BYT dated October 31, 2001 of the Minister of Health on "Strengthening HIV Testing Work."

d) The HIV test result report of blood donors, blood components, sperm, ova, tissue, or organ donors must be stored in the medical record according to the "Hospital Rules" issued together with Decision No. 1895/1997/QĐ-BYT dated September 19, 1997 of the Minister of Health.

3. Provisions on storing samples for HIV screening tests during blood transfusions:

a) After blood collection, each blood bag must be sealed and separated with a segment of tubing approximately 7 cm to 10 cm long from the blood collection tube, which includes the blood bag code.

b) The separated tubing segment must be centrifuged and separated into plasma and red blood cells. The plasma segment with full code must be stored in a freezer or deep freezer at -30°C for two years.

c) The laboratory department is responsible for managing the cold storage area for sample preservation according to specific management rules. Access to samples for research or other purposes can only be done with the approval of the health facility director.^°d) In the blood collection and distribution logbook, healthcare staff must record the blood bag code and blood product code for easy reference when needed.

4. Provisions on reporting HIV-positive cases:

a) When HIV screening tests detect a positive case, health facilities must send the blood sample to a laboratory recognized by the Ministry of Health to confirm the positive case.

b) After confirmation, the laboratory must inform the sending health facility to provide counseling to the blood donor, blood component, sperm, ova, tissue, or organ donor, and report according to the provisions in the "National HIV/AIDS Surveillance Guidelines" issued together with Decision No. 1418/2000/QĐ-BYT dated May 4, 2000 of the Minister of Health.

a) When initial screening tests detect HIV positive results, healthcare facilities must send the blood sample to a laboratory recognized by the Ministry of Health as having the necessary conditions to confirm HIV positive cases for confirmatory testing.

b) After testing and confirmation, the laboratory must inform the healthcare facility that sent the sample about the result to provide counseling to the blood donor, blood components, sperm, ova, tissue, or body parts, while also reporting according to the regulations set forth in the "Standard Procedures for Monitoring HIV/AIDS in Vietnam" issued with Decision No. 1418/2000/QĐ-BYT dated May 4, 2000, of the Minister of Health./.