Directive No. 11/2001/CT-BYT on Strengthening Testing Work to Detect HIV Viruses

DIRECTIVE

On Strengthening HIV Testing Work

_____________________________

 HIV testing is one of the top priorities in the work of preventing HIV/AIDS infection not only in our country but also worldwide. Effectively implementing HIV testing work will help professionals accurately and comprehensively assess the HIV transmission situation, thereby enabling timely and effective interventions to reduce the impact of the HIV/AIDS pandemic; accurate HIV test results will contribute to ensuring safety in blood transfusions and limiting HIV transmission through medical services.

Currently, the HIV testing system in our country includes:

- Laboratories under the Preventive Health Centers of provinces and centrally governed cities (referred to collectively as provinces), which have the function of being the focal point for monitoring HIV in their respective areas;

- Laboratories under healthcare facilities that perform HIV screening for blood donors to ensure safe blood transfusions and prevent HIV transmission through blood, while also having the responsibility to monitor and diagnose HIV in patients;

- HIV laboratories under the Central Institute of Hygiene and Epidemiology and regional Pasteur Institutes responsible for monitoring HIV in their regions and rechecking HIV test results sent from provincial health prevention centers.

With this testing system, we have achieved some notable accomplishments in recent years, contributing to limiting HIV transmission, ensuring 100% of blood bags and blood products are screened for HIV before being transfused to patients; relatively accurately assessing the HIV transmission situation. However, upon inspecting HIV laboratories under the health prevention centers of 18 southern and central provinces to consider recognizing them as qualified laboratories capable of confirming HIV-positive cases (as stipulated in Decision No. 3052/2000/QĐ-BYT dated August 29, 2000 issued by the Minister of Health on "Criteria for Laboratories Authorized to Confirm HIV-Positive Cases"), only nine laboratories met the criteria and were recognized by the Ministry of Health in Decision No. 3573/2001/QĐ-BYT dated August 20, 2001. The HIV laboratories under the health prevention centers of other provinces were not recognized as qualified to confirm HIV-positive cases due to one of the following reasons: staff directly involved in HIV testing did not fully grasp the testing procedures and methods; the rotation of HIV testing staff to other positions while replacement staff lacked expertise in testing; HIV laboratories did not meet the required standards, lacked testing equipment or had broken equipment that had not been repaired... leading to inaccurate testing results; reporting of test results was not consistent.

To address these issues and enhance the effectiveness of HIV/AIDS prevention and control activities throughout the healthcare sector, the Minister of Health instructs heads of units under the Ministry, Provincial Health Directors, and Heads of Health Departments to immediately implement the following requirements:

1. The Provincial Health Prevention Center is the sole entity authorized to publish HIV/AIDS infection data in its jurisdiction. The publication of HIV-positive cases must be carried out in accordance with legal regulations.

2. After conducting tests, HIV laboratories must retain serum samples for two years if HIV-positive cases are detected, and keep ELISA machine reading results for five years.

3. HIV laboratories recognized by the Ministry of Health as meeting the criteria and conditions to confirm HIV-positive cases need to take proactive measures to maintain and meet the requirements of a laboratory that meets the standards set forth in Decision No. 3052/2000/QĐ-BYT dated August 29, 2000 issued by the Minister of Health. Staff engaged in HIV testing should not be transferred when there is no qualified replacement available. In necessary cases where transfer is required, the replacement staff must be trained, evaluated, and certified as qualified by the Central Institute of Hygiene and Epidemiology or regional Pasteur Institutes according to the standards specified in Decision No. 3052/2000/QĐ-BYT dated August 29, 2000 issued by the Minister of Health.

4. For laboratories that have been inspected and evaluated by the Ministry of Health but have not met the criteria set forth in the "Criteria for Laboratories Authorized to Confirm HIV-Positive Cases" issued in Decision No. 3052/2000/QĐ-BYT dated August 29, 2000 by the Minister of Health, the heads of units with such laboratories must urgently address the unmet criteria based on the recommendations of the Ministry of Health's evaluation team. Upon addressing the issues, they must submit a report to the Ministry of Health requesting re-evaluation.

During the waiting period for re-evaluation, HIV laboratories must continue conducting HIV tests, sending suspicious or confirmed positive samples to the Central Institute of Hygiene and Epidemiology and regional institutes for confirmation. The Central Institute of Hygiene and Epidemiology and regional institutes are responsible for responding within seven days of receiving the sample.

5. HIV laboratories that have been inspected and evaluated by the Central Institute of Hygiene and Epidemiology and regional institutes as meeting the criteria but have not been recognized by the Ministry of Health must regularly self-inspect, correct deficiencies, and improve themselves. The Ministry of Health will conduct evaluations to issue recognition decisions.

For laboratories that have been inspected and evaluated by regional institutes but have not met the criteria, the Provincial Health Prevention Center must address the unmet criteria. Upon addressing the issues, they must submit a report to the regional institute and the Ministry of Health for inspection and evaluation.

6. The Central Institute of Hygiene and Epidemiology is responsible for coordinating with the Ho Chi Minh City Pasteur Institute, Nha Trang Pasteur Institute, and West Region Institute of Hygiene and Epidemiology to carry out the following tasks:

6.1. Conduct inspections of HIV testing laboratories (including hospital laboratories) that have not met the standards and report the inspection results to the Ministry of Health. In addition to reporting on laboratories that meet the standards, also report on those that do not meet the standards; at the same time, the report must clearly state the points that need to be addressed to be able to confirm positive HIV test results.

6.2. Regularly train HIV testing techniques, focusing on ELISA machine testing techniques, laboratory management techniques, sample storage, regular monitoring of HIV/AIDS/STI... The training must combine theory and practice, organize practical skill tests, and issue certificates to trainees (certificates are only issued to trainees who pass both the theoretical and practical exams at the Institute) immediately upon completion of the training course.

6.3. Develop panels and samples for laboratories, forms, and record books in accordance with the regulations of the Regular Monitoring of HIV/AIDS in Vietnam, and submit them to the Minister of Health for issuance and uniform application for all HIV testing laboratories nationwide.

7. The Central Institute of Hygiene and Epidemiology, the Ho Chi Minh City Pasteur Institute, the Nha Trang Pasteur Institute, and the West Region Institute of Hygiene and Epidemiology must strengthen periodic and spot inspections of laboratories recognized by the Ministry of Health as meeting the standards pursuant to Decision No. 3052/2000/QĐ-BYT dated August 29, 2000 of the Minister of Health, and report the inspection results immediately to the Ministry of Health (Preventive Medicine Department).

Upon receipt of this Directive, heads of units under the Ministry, provincial health department directors, and health sector heads must immediately implement the requirements set forth above and report the results to the Ministry of Health (Preventive Medicine Department) by December 30, 2001.