Circular No. 42/2013/TT-BYT amends and supplements Circular No. 15/2013/TT-BYT dated May 24, 2013 on ensuring quality in implementing HIV testing techniques.

CIRCULAR

Amending and supplementing Circular No. 15/2013/TT-BYT dated May 24, 2013 guiding quality assurance for HIV testing techniques

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Pursuant to the Law on Prevention and Control of Viruses Causing AIDS (HIV/AIDS) dated June 29, 2006;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Department of HIV/AIDS Prevention and Control, and the Head of the Legal Department;

The Ministry of Health issues this Circular amending and supplementing Circular No. 15/2013/TT-BYT dated May 24, 2013 guiding quality assurance for HIV testing techniques.

Article 1. Amending and supplementing Clause 3, Article 17 of Circular No. 15/2013/TT-BYT dated May 24, 2013 guiding quality assurance for HIV testing techniques (hereinafter referred to as Circular No. 15/2013/TT-BYT) as follows:

"3. A list of personnel of the laboratory according to the model prescribed in Appendix 2 issued together with this Circular, accompanied by a copy of the certificate of training in HIV testing issued by health facilities designated by the Minister of Health or a certificate of training in HIV testing issued by competent authorities abroad, which is appropriate to the testing technique assigned to that person. For laboratories under medical examination and treatment facilities, they must also submit a certified copy of the practice license of the laboratory staff.

Article 2. Amending and supplementing Article 18 of Circular No. 15/2013/TT-BYT as follows:

"Article 18. Procedures for announcing laboratories meeting conditions to conduct HIV screening tests

1. Procedures for announcing meeting conditions for HIV testing for laboratories under medical examination and treatment facilities:

a) In the case of newly established medical examination and treatment facilities: The procedures for announcing meeting conditions for HIV testing are carried out simultaneously with the procedures for requesting the issuance of the Operating Permit of the facility;

b) In the case of medical examination and treatment facilities under the management of provincial-level Departments of Health (hereinafter referred to as provinces) and Ministries and sectors that have been operating and newly establish HIV laboratories:

- Before conducting HIV screening tests, the facility where the HIV laboratory is located must submit one set of documents as prescribed in Article 17 of this Circular to the provincial Department of Health where the facility is headquartered;

- After receiving the documents, the provincial Department of Health sends the facility submitting the documents a receipt for acceptance of the documents according to the model prescribed in Appendix 4 issued together with this Circular;

- Within fifteen working days from the date recorded on the receipt for acceptance of the documents, if the provincial Department of Health does not propose amendments or supplements, the facility is permitted to commence HIV testing activities;

- If the documents are not valid, within five working days from the date of receipt of the documents, the provincial Department of Health must issue a document proposing the facility to amend and supplement. The document proposing amendments and supplements must specify which documents need to be supplemented and which contents need to be amended;

- Upon receiving the document requesting amendments and supplements, the facility announcing meeting conditions for HIV testing must carry out amendments and supplements according to the contents specified in the document and submit the amended and supplemented documents to the provincial Department of Health;

- Within fifteen working days from the date recorded on the receipt for acceptance of the supplementary documents, if the provincial Department of Health does not propose amendments or supplements, the facility is permitted to commence HIV testing activities.

c) In the case of medical examination and treatment facilities under the management of the Ministry of Health that have been operating and newly establish HIV laboratories:

- Before conducting HIV screening tests, the facility where the HIV laboratory is located must submit one set of documents as prescribed in Article 17 of this Circular to the Ministry of Health (Department of HIV/AIDS Prevention and Control);

- After receiving the documents, the Ministry of Health sends the facility submitting the documents a receipt for acceptance of the documents according to the model prescribed in Appendix 4 issued together with this Circular;

- Within fifteen working days from the date recorded on the receipt for acceptance of the documents, if the Ministry of Health does not propose amendments or supplements, the facility is permitted to commence HIV testing activities;

- If the documents are not valid, within five working days from the date of receipt of the documents, the Ministry of Health must issue a document proposing the facility to amend and supplement. The document proposing amendments and supplements must specify which documents need to be supplemented and which contents need to be amended;

- Upon receiving the document requesting amendments and supplements, the facility announcing meeting conditions for HIV testing must carry out amendments and supplements according to the contents specified in the document and submit the amended and supplemented documents to the Ministry of Health;

- Within fifteen working days from the date recorded on the receipt for acceptance of the supplementary documents, if the Ministry of Health does not propose amendments or supplements, the facility is permitted to commence HIV testing activities.

2. Procedures for announcing meeting conditions for HIV testing for laboratories under the management of provincial-level Departments of Health and Ministries and sectors but not being medical examination and treatment facilities: The procedures for announcing meeting conditions for HIV testing are implemented according to Point b, Clause 1 of this Article;

3. Procedures for announcing meeting conditions for HIV testing for laboratories under the management of the Ministry of Health but not being medical examination and treatment facilities: The procedures for announcing meeting conditions for HIV testing are implemented according to Point c, Clause 1 of this Article."

Article 3. Amend and supplement Point c Clause 3 Article 19 Circular No. 15/2013/TT-BYT as follows:

"c) Within 20 working days, from the date of receiving the report from the requesting entity, the inspection entity must carry out:

- Evaluate the results of the specimen samples sent by the requesting entity;

- Evaluate the results of the proficiency testing sample for HIV testing capability sent by the inspection entity;

- Organize on-site inspection at the requesting entity.

After completing the evaluation, the inspection entity shall be responsible for sending the results to the Department of HIV/AIDS Prevention and Control - Ministry of Health according to the form prescribed in Appendix 5 issued together with this Circular;"

Article 4. Amend and supplement Article 23 Circular No. 15/2013/TT-BYT as follows:

"Article 23. Cases of Suspension of Activities

An HIV laboratory will have its activities suspended in the following cases:

1. Failure to comply with testing procedures or having technical errors in testing as guided by the Minister of Health but not affecting the test results.

2. Personnel of the laboratory do not meet the conditions stipulated in this Circular.

3. Lack of sufficient equipment for testing or having testing equipment that does not function or does not ensure quality.

4. Infrastructure does not meet the conditions stipulated in this Circular.

5. Failure to participate in external quality control programs."

Article 5. Amend and supplement Article 31 Circular No. 15/2013/TT-BYT as follows:

"Article 31. Transitional Provisions

1. New HIV laboratories established or renovated after the effective date of this Circular must comply with all conditions stipulated in this Circular.

2. Existing HIV screening laboratories operating before the effective date of this Circular may continue their operations but must develop plans to renovate to meet all conditions stipulated in this Circular and must complete the procedure to declare compliance with HIV testing conditions as prescribed in Article 1 of this Circular by December 31, 2014.

3. HIV laboratories recognized by the Ministry of Health as meeting the conditions for confirming positive HIV test results before the effective date of this Circular may continue their operations but must submit the dossier as prescribed in Article 17 of this Circular along with all annual inspection reports from regional institutes to the Department of HIV/AIDS Prevention and Control - Ministry of Health for review by December 31, 2014.

In case the HIV laboratory meets the conditions stipulated in this Circular, the Department of HIV/AIDS Prevention and Control - Ministry of Health shall be responsible for submitting to the leadership of the Ministry of Health for consideration and decision on issuing a certificate for the HIV confirmation laboratory.

In case the HIV laboratory does not meet the conditions stipulated in this Circular, the Department of HIV/AIDS Prevention and Control - Ministry of Health shall be responsible for submitting to the leadership of the Ministry of Health for consideration and decision on revoking the recognition of the laboratory's ability to confirm positive HIV cases."

Article 6. Effectiveness

This Circular takes effect from January 15, 2014.

Article 7. Responsibility for Implementation

The Director of the Office of the Ministry, the Director of the Department of HIV/AIDS Prevention and Control, the Heads of Departments, Directors of Bureaus, General Directors of General Bureaus under the Ministry of Health, Heads of agencies and units directly under the Ministry, Provincial Health Directors of centrally governed cities and Heads of health agencies of ministries and sectors are responsible for implementing this Circular.

During implementation, if difficulties arise, units and localities should report to the Ministry of Health for research and resolution./.