Circular No. 04/2019/TT-BYT stipulates the分级权限发放、调整和收回确认HIV阳性病例的检测资格证书以及暂停确认HIV阳性病例检测活动的权力。

CIRCULAR

REGULATIONS ON THE DELEGATION OF AUTHORITY FOR ISSUING, AMENDING, REVOKING LICENSES FOR HIV POSITIVE CASE CONFIRMATION TESTING AND SUSPENDING HIV POSITIVE CASE CONFIRMATION TESTING ACTIVITIES

Pursuant to the Law on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS) dated June 29, 2006;

Pursuant to Decree No. 75/2016/NĐ-CP dated July 1, 2016 of the Government stipulating conditions for conducting HIV testing;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the proposal of the Director of the HIV/AIDS Prevention and Control Department;

The Minister of Health issues this Circular regulating the delegation of authority for issuing, amending, revoking licenses for HIV positive case confirmation testing and suspending HIV positive case confirmation testing activities.

Article 1. Delegation to the Director General of the Department of HIV/AIDS Prevention and Control

The Director General of the Department of HIV/AIDS Prevention and Control shall issue, amend, revoke licenses for HIV positive case confirmation testing and suspend HIV positive case confirmation testing activities in accordance with Article 6 of Decree No. 75/2016/NĐ-CP dated July 1, 2016 of the Government stipulating conditions for conducting HIV testing (hereinafter referred to as Decree No. 75/2016/NĐ-CP) for the following health facilities:

1. Health facilities under the Ministry of Health.

2. Health facilities under other Ministries and sectors.

Article 2. Delegation to the Director of the Provincial Health Department

The Director of the Provincial Health Department (hereinafter referred to as the Provincial Health Department) shall issue, amend, revoke licenses for HIV positive case confirmation testing and suspend HIV positive case confirmation testing activities in accordance with Article 6 of Decree No. 75/2016/NĐ-CP for the following health facilities:

1. Health facilities under the Provincial Health Department.

2. Private health facilities within the management area of the Provincial Health Department.

Article 3. Guidelines for the inspection team for issuing licenses for HIV positive case confirmation testing

1. The Director General of the Department of HIV/AIDS Prevention and Control decides to establish an inspection team for issuing licenses for HIV positive case confirmation testing consisting of the following members:

a) A representative from the leadership of the Department of HIV/AIDS Prevention and Control serving as the head of the team;

b) An officer responsible for HIV testing activities at the Department of HIV/AIDS Prevention and Control;

c) An expert in HIV testing with at least five years of experience in performing confirmatory HIV positive testing using techniques appropriate to the techniques proposed by the health facility for inspection;

d) Other members as necessary.

2. The Director of the Provincial Health Department decides to establish an inspection team for issuing licenses for HIV positive case confirmation testing consisting of the following members:

a) A representative from the leadership of the Provincial Health Department serving as the head of the team;

b) An expert in testing with at least five years of experience in performing confirmatory HIV positive testing using techniques appropriate to the techniques proposed by the health facility for inspection;

c) A representative from the leading unit for HIV/AIDS prevention and control at the provincial level.

d) Other members as necessary.

Article 4. Effective date

This Circular takes effect from May 30, 2019.

Article 5. Transitional Provisions

1. Applications submitted to the Ministry of Health (Department of HIV/AIDS Prevention and Control) for issuing, amending, revoking licenses for HIV positive case confirmation testing and suspending HIV positive case confirmation testing activities before the effective date of this Circular shall continue to be processed in accordance with Decree No. 75/2016/NĐ-CP.

2. Licenses for HIV positive case confirmation testing issued before the effective date of this Circular remain valid. In cases where a new license needs to be issued, amended, or revoked, health facilities shall follow the provisions of this Circular.

Article 6. Responsibility for Implementation

1. The Director General of the Department of HIV/AIDS Prevention and Control is responsible for:

a) Organizing guidance, implementation, and supervision of the implementation of this Circular nationwide;

b) Issuing, amending, revoking licenses for HIV positive case confirmation testing and suspending HIV positive case confirmation testing activities within the scope of delegated authority as stipulated in Article 1 of this Circular;

c) Publishing a list of health facilities with laboratories that have been issued, amended, or had their licenses revoked for HIV positive case confirmation testing and suspended HIV positive case confirmation testing activities on the Ministry of Health's website;

d) Announcing administrative procedures and publicly posting administrative procedures in accordance with regulations.

2. The Director of the Provincial Health Department shall be responsible for:

a) Organizing guidance, implementation, and supervision of the implementation of this Circular within the management area;

b) Issuing, amending, revoking licenses for HIV positive case confirmation testing and suspending HIV positive case confirmation testing activities within the scope of delegated authority as stipulated in Article 2 of this Circular;

c) Publishing a list of health facilities with laboratories that have been issued, amended, or had their licenses revoked for HIV positive case confirmation testing and suspended HIV positive case confirmation testing activities on the Provincial Health Department's website;

d) Reporting annually to the Department of HIV/AIDS Prevention and Control on the results of issuing, amending, revoking licenses for HIV positive case confirmation testing and suspending HIV positive case confirmation testing activities;

e) Announcing administrative procedures and publicly posting administrative procedures in accordance with regulations.

3. The Head of the Office of the Ministry, the Inspector General of the Ministry, the Director General of the Department of HIV/AIDS Prevention and Control, the Heads of Departments, Directors of Bureaus, and General Directors under the Ministry of Health, the Heads of agencies and units directly under the Ministry, the Directors of Provincial Health Departments, the Heads of health agencies under other Ministries and sectors, and related organizations and individuals are responsible for implementing this Circular. Any difficulties encountered during implementation should be promptly reported to the Ministry of Health (Department of HIV/AIDS Prevention and Control) for research and resolution.

During implementation, any difficulties shall be promptly reported to the Ministry of Health (HIV/AIDS Prevention and Control Department) for research and resolution./.