Decision No. 175/2001/QĐ-BYT on issuing the "Professional Regulations for Blood Testing to Prevent HIV/AIDS Transmission"

Pursuant to …;

Regarding the issuance of "Professional Regulations for Blood Testing to Prevent HIV/AIDS Infection"

- Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government on tasks, powers, and organizational structure of the Ministry of Health;

_________________

THE MINISTER OF HEALTH

- Pursuant to Article 14 of the Ordinance on Prevention and Control of Human Immunodeficiency Virus (HIV) Infection/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 Human Immunodeficiency Virus (HIV) Infection/AIDS;

- Based on the proposal of the Director of the Department of Preventive Medicine, the Director of the Department of Treatment - Ministry of Health,

Issued along with this Decision are "Professional Regulations for Blood Testing to Prevent HIV/AIDS Infection"

Pursuant to …;

Article 1. This Decision shall apply to state-owned, private, semi-public, and self-established medical facilities, as well as foreign-invested medical facilities.

Article 2. All officials: Chief of Office, Chief Inspector, Heads of Departments under the Ministry of Health, Director of the Vietnam Drug Administration, Directors of Provincial Health Services, Central City Health Services, Heads of Units under the Ministry of Health, and Sectoral Health Leaders are responsible for implementing this Decision.

Article 3. This Decision shall take effect fifteen days from the date of issuance.

Article 4. PROFESSIONAL REGULATIONS FOR BLOOD TESTING TO PREVENT HIV/AIDS INFECTION

REGULATIONS

(Issued together with Decision No.: 175/2001/QĐ-BYT

dated January 18, 2001 of the Minister of Health)

These regulations guide the screening tests for HIV in cases of blood transfusion, artificial insemination, tissue transplantation, or organ transplantation:

1. For blood transfusion cases, there is no need to test the blood donor; only a screening test for HIV should be conducted directly on the blood bag or bottle (referred to collectively as the blood bag).

_______________

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. For cases of artificial insemination, tissue transplantation, or organ transplantation: A screening test for HIV must be performed on the blood of the sperm donor, tissue donor, or organ donor.

1. Regulations on HIV/AIDS Screening Tests:

1.1. All blood bags must undergo an HIV screening test before transfusion, including in emergency situations.

1. Provisions on HIV screening tests:

1.2. The sperm donor, tissue donor, or organ donor must undergo an HIV screening test prior to donation.

1.3. The HIV screening test must be conducted using diagnostic reagents for HIV that have been registered for circulation in Vietnam by the Ministry of Health.

2. Regulations on Screening Tests for Other Infectious Diseases Transmitted Through Blood Transfusion:

The screening tests for other infectious diseases transmitted through blood transfusion must be carried out in accordance with the Blood Transfusion Directive issued in Decision No. 937/BYT-QĐ dated September 4, 1992 of the Minister of Health.

3. Regulations on Recording and Storing Test Forms:

3.1. All HIV testing cases must be fully recorded in the patient's medical record. If the result is positive for HIV, it must be clearly marked as "positive"; if negative, it must be clearly marked as "negative".

3.2. Blood bags that are negative for HIV must be clearly marked as "negative" on the test form. The test form must include the following information:

a. Date, month, year of the test.

b. Location where the test was conducted.

c. Technician conducting the test.

d. Testing technique.

e. Diagnostic reagent used.

f. Test results.

The test form must be written in non-fading ink and affixed or securely attached to the tested blood bag.

3.3. After the blood bag has been transfused to the patient, the medical facility must retain the test form and store it in the patient's medical record according to the "Hospital Regulations" issued in Decision No. 1895/QĐ-BYT dated September 19, 1997 of the Minister of Health.

4. Regulations on Reporting Positive HIV Cases:

When a screening test detects a positive HIV case, the medical facility must send the blood sample to a location with the necessary conditions to confirm positive HIV cases as stipulated in Decision No. 3052/2000/QĐ-BYT dated August 29, 2000 of the Minister of Health for further testing. After confirmation, the testing facility must inform the medical facility about the results to provide counseling to the blood donor, sperm donor, tissue donor, or organ donor, and report the case in accordance with the "Standard Procedures for HIV/AIDS Surveillance in Vietnam" issued in Decision No. 1418/2000/QĐ-BYT dated May 4, 2000 of the Minister of Health.

4/ Provisions on reporting positive HIV cases:

When screening tests detect positive HIV results, healthcare facilities must send the blood sample to a facility with the necessary conditions to confirm positive HIV cases according to Decision No. 3052/2000/QĐ-BYT dated August 29, 2000, of the Minister of Health for further testing. After testing and confirmation, the testing facility must inform the healthcare facility to provide counseling to blood donors, sperm donors, tissue donors, or organ donors, while also reporting in accordance with the "Standard Procedures for Monitoring HIV/AIDS in Vietnam" issued by Decision No. 1418/2000/QĐ-BYT dated May 4, 2000, of the Minister of Health.