Nghị định 75/2016/ND-CP

DECREE

CONDITIONS FOR HIV TESTING

Pursuant to the Law on Government organization dated June 19, 2015;

Pursuant to the Law on Investment dated November 26, 2014;

Pursuant to the Law on prevention of Human Immunodeficiency Virus (HIV/AIDS) dated June 29, 2006;

At the request of the Minister of Health;

The Government promulgates a Decree on conditions for HIV testing.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Decree provides for conditions for testing HIV, which consists of screening tests and HIV confirmatory tests, documentation and procedures for issuance, reissuance, revocation of certificate of eligibility to run HIV confirmatory tests (hereinafter referred to as certificate of eligibility) and suspension of HIV confirmatory tests.

Article 2. Regulated entities

This Decree applies to organizations and individuals involved in HIV testing.

Article 3. Definitions

For the purpose of this Decree, the terms below are construed as follows:

1. HIV screening test means a testing technique using 01 highly sensitive HIV biological to detect possible cases of HIV infection.

2. Confirmatory testing of HIV-positive samples (hereinafter referred to as “HIV confirmatory tests”) means testing techniques using 03 biologicals with different principles or antigens to confirm HIV infection in HIV-positive samples obtained from HIV screening tests.

Chapter II

CONDITIONS TO BE SATISFIED BY HIV TESTING LABORATORIES

Article 4. Conditions to be satisfied by laboratories running HIV screening tests

1. Personnel:

There is at least 01 tester who:

a) has a practicing certificate suitable for the testing; or

b) is trained in HIV testing.

2. The laboratory has equipment for testing, preserving biologics and specimens suitable for HIV testing techniques employed by such laboratory.

3. Infrastructure:

a) Materials in the testing area are waterproof and resistant to high temperature and corrosive chemicals. The testing area is sufficiently lighted, airy, clean, protected from dirt, humidity, and has clean water supply;

b) Testing tables can be easily cleaned with common detergents, placed at sufficiently lighted and windless positions;

c) Hand washing stations are available;

d) There is equipment or measures for treating wastes before they are moved to the common waste dump.

Article 5. Conditions to be satisfied by laboratories running confirmatory HIV tests

1. Personnel:

a) The person in charge shall have at least a bachelor’s degree in health, pharmacy, biology or chemistry and at least 24 months’ experience of testing, including at least 06 months’ experience of HIV testing;

b) Every HIV tester shall have at least 06 months’ experience of HIV testing.

2. Equipment requirements:

a) There is equipment for testing and preserving biologics and specimens suitable for the HIV testing techniques employed by the laboratory;

b) There is equipment for preserving specimens at -20°C or lower.

3. Infrastructure of the laboratory shall satisfy the conditions specified in Clause 3 Article 4 of this Decree.

4. A HIV testing laboratory must:

a) Have run confirmatory HIV tests for at least 03 months before submission of the application for the certificate of eligibility;

b) At least 30 suspected HIV-positive samples are obtained during the period specified in Point a of this Clause. In case of testing by machine, a technique must be performed at least 20 times;

c) Pass the inspection for HIV testing capacity as confirmed by an HIV testing laboratory appointed by the Ministry of Health or a foreign HIV testing laboratory recognized by the Ministry of Health (hereinafter referred to as reference HIV testing laboratory). The HIV testing capacity inspection requires that:

- Test results of 30 samples (comprising 20 positive samples and 10 negative samples) tested by the applying laboratory and the reference laboratory are the same;

- Test results of reference samples sent by the reference laboratory to the applying laboratory are accurate.

Chapter III

POWER, DOCUMENTATION AND PROCEDURES FOR ISSUANCE, REISSUANCE, REVOCATION OF CERTIFICATE OF ELIGIBILITY AND SUSPENSION OF HIV CONFIRMATORY TESTS

Article 6. The power to issue, adjust, revoke certificates of eligibility and suspend HIV confirmatory tests

The Ministry of Health or any agency authorized by the Ministry of Health (hereinafter referred to as competent authority) has the power to issue, adjust, revoke certificates of eligibility and suspend HIV testing laboratories from running HIV confirmatory tests.

Article 7. Issuance of certificate of eligibility

1. A new certificate of eligibility shall be granted to a laboratory applying for the certificate for the first time (hereinafter referred to as applicant).

2. A certificate of eligibility shall be reissued if:

a) It is damaged or lost; or

b) An unexpired certificate of confirmatory HIV testing laboratory is issued before the promulgation of this Decree.

Article 8. Application for issuance or reissuance of certificate of eligibility

1. An application for issuance of a new certificate of eligibility consists of:

a) An application form (Form No. 01 enclosed herewith);

b) A list of person in charge and testers of the applicant (Form No. 04 enclosed herewith);

c) A list of equipment of the applicant (Form No. 05 enclosed herewith);

d) A site plan of the testing area;

dd) Copies of confirmations of HIV testing results specified in Point c Clause 4 Article 5 of this Decree.

2. An application for reissuance of a certificate of eligibility consists of the application form No. 02 enclosed herewith.

Article 9. Procedures for issuance of a new certificate of eligibility

1. The applicant shall submit 01 application directly or by post to a competent authority specified in Article 6 of this Article.

2. Within 05 working days from the day on which the application is received, the competent authority shall send a notice of receipt (Form No. 06) to the applicant.

3. If the application is not satisfactory, within 07 working days from the date written on the notice of receipt, the competent authority shall request the applicant in writing to complete the application. The written request shall specify necessary adjustments and/or additions. The applicant shall complete the application according to the request and send it to the competent authority.

4. If the application is satisfactory, the competent authority shall carry out a site inspection in accordance with Clause 5 of this Article within 30 days from the date written on the notice of receipt.

5. Site inspection procedures:

a) The competent authority shall establish an inspectorate which consists of representatives of the competent authority, HIV testing experts, and other members;

b) The inspectorate shall inspect the satisfaction of conditions specified in Article 5 of this Decree and testing techniques instructed by the Ministry of Health, including: infrastructure, equipment, personnel, documents, HIV testing capacity, management of specimens, biologics, supplies, and waste treatment;

c) An inspection record shall be made out into 04 copies; two are kept by the competent authority, one is sent to the Ministry of Health and 01 is kept by the applicant.

6. If all conditions for running confirmative HIV tests are satisfied, the competent authority shall issue the certificate of eligibility (Form No. 07 enclosed herewith) within 10 working days from the end of the inspection (according to the inspection record).

7. Within 10 days from the issuance date of the certificate of eligibility, the competent authority shall post on its website a notice of the laboratory granted the certificate.

8. Validity period of a certificate of eligibility issued is indefinite.

Article 10. Procedures for reissuance of a certificate of eligibility

1. The applicant shall submit an application for reissuance of the certificate of eligibility to a competent authority.

2. After receiving the application, the competent authority shall send a notice of receipt (Form No. 06) to the applicant.

3. Within 10 working days from the date written on the notice of receipt, the competent authority shall reissue the certificate of eligibility.

Article 11. Adjusting a certificate of eligibility

1. A certificate of eligibility will be adjusted if:

a) The name of the HIV testing laboratory is changed;

b) The person in charged is replaced;

c) The HIV testing technique is changed; or

d) Location of the laboratory is changed.

2. Composition of an application for reissuance of the certificate of eligibility:

a) In the case specified in Point a or Point d Clause 1 of this Article: Application form No. 03 enclosed herewith, certified true copies of documents proving the change in the name of location of the laboratory.

b) In the case specified in Point b Clause 1 of this Article: Application form No. 03 enclosed herewith, certified true copies of qualifications of the person in charge;

c) In the case specified in Point c Clause 1 of this Article: Application form No. 03 enclosed herewith, certified true copies of the HIV test result confirmation after the testing technique is changed as specified in Point c Clause 4 Article 5 of this Decree.

3. After receiving the application, the competent authority shall send a notice of receipt (Form No. 06) to the applicant.

4. If the application is not satisfactory, within 10 working days from the date written on the notice of receipt, the competent authority shall request the applicant in writing to complete the application. The written request shall specify necessary adjustments and/or additions. The applicant shall complete the application according to the request and send it to the competent authority.

5. If the application is satisfactory, within 15 working days from the date written on the notice of receipt, the competent authority shall issue the adjusted certificate of eligibility to the applicant. If the application is rejected, the competent authority shall respond and provide explanation in writing.

Article 12. Suspension of HIV confirmatory tests

1. HIV confirmatory tests shall be suspended in case of:

a) failure to satisfy any of the conditions specified in Article 5 of this Decree; or

b) failure to apply for adjustments to the certificate of eligibility in case of any changes specified in Clause 1 Article 11 of this Decree.

2. During the inspection, if any of the violations specified in Clause 1 of this Article is found, the inspectorate shall send a request for suspension of confirmatory HIV tests to the competent authority within 05 working days.

3. As soon as such request is made out, the laboratory shall suspend all confirmatory HIV tests until an official decision on suspension is issued by the competent authority.

4. Within 10 days from the day on which the request for suspension is received, the competent authority shall consider issuing a decision on suspension.

5. Within 06 months from the issuance date of the decision on suspension, the laboratory shall rectify the violations at the request of the inspecting authority. After all violations are rectified, the laboratory shall send a report to the competent authority as the basis for the competent authority to consider lifting the suspension.

6. If the laboratory fails to submit such report within the time limit specified in Clause 5 of this Article or the rectification is not satisfactory, the competent authority shall revoke the certificate of eligibility.

Article 13. Cases of revocation of certificate of eligibility

1. A certificate of eligibility shall be revoked if:

a) any of the violations specified in Clause 6 Article 12 of this Decree is committed;

b) any of documents in the application for the certificate of eligibility is fraudulent; or

c) the new certificate of eligibility is lent or borrowed or falsified.

2. Procedures for revocation of a certificate of eligibility

a) During the inspection, if any of the violations specified in Point b or c Clause 1 of this Article is found, the inspectorate shall send a request for suspension of confirmatory HIV tests to the competent authority.

b) Within 10 days from the day on which the request for suspension is received, the competent authority shall consider issuing a decision on revocation of the certificate of eligibility;

c) In case of violation specified in Point a Clause 1 of this Article, the competent authority shall apply Clause 6 Article 12 of this Decree.

Chapter IV

RESPONSIBILITY FOR IMPLEMENTATION

Article 14. Responsibilities of a HIV testing laboratory

1. Conduct HIV tests in accordance with instructions of the Ministry of Health.

2. Comply with decisions on inspections by competent authorities, provisions of this Decree and other regulations of law.

3. Discover and report substandard biologics and testing equipment.

4. Stop HIV tests, notify relevant parties, and take appropriate measures upon discovery of unconformable HIV testing.

5. Fulfill other obligations prescribed by law.

Article 15. Responsibilities of the Ministry of Health

1. Formulate and promulgate legislative documents on management of HIV testing or request a competent authority to do so, plans for development of the system of HIV testing laboratories.

2. Provide instructions on, disseminate and organize implementation of legislative documents on management of HIV testing, plans for development of the system of HIV testing laboratories.

3. Carry out inspections, settle complaints, denunciations and take actions against violations against regulations on HIV testing.

4. Develop training programs, provide training; conduct research and apply technological advances to HIV testing.

5. Transfer documents about laboratories granted certificates of eligibility before this Decree comes into force to agencies authorized by the Ministry of Health as prescribed in Article 6 of this Decree.

6. Publish a list of reference HIV testing laboratories on the website of the Ministry of Health.

Article 16. Responsibilities of the People’s Committees of provinces

1. Provide guidelines; manage activities pertaining to HIV testing services in their provinces as prescribed by law.

2. Carry out inspections, settle complaints, denunciations and take actions against violations against regulations on HIV testing.

3. Instruct specialized agencies to issue, adjust, revoke certificates of eligibility and suspend HIV testing laboratories from running HIV confirmatory tests.

Chapter V

IMPLEMENTATION CLAUSE

Article 17. Effect

This Decree comes into force from July 01, 2016.

Article 18. Transition clause

HIV testing laboratories granted certificates of eligibility before this Decree comes into force may keep operating until their certificates expire. Any of them that wishes to have the certificate of eligibility adjusted during such period shall follow procedures specified in Article 11 of this Decree.

Any HIV testing laboratory whose certificate of eligibility expires shall follow procedures for reissuance specified in Article 10 of this Decree.

Article 19. Organizing implementation

Ministers, Heads of ministerial agencies, Heads of Governmental agencies, Presidents of the People’s Committees of provinces are responsible for implementation of this Decree./.