Conditions to be satisfied by laboratories running HIV screening tests in Vietnam

Conditions to be satisfied by laboratories running HIV screening tests in Vietnam (Internet image) 

Regarding this issue, LawNet would like to answer as follows:

1. Conditions to be satisfied by laboratories running HIV screening tests in Vietnam

Conditions to be satisfied by laboratories running HIV screening tests in Vietnam according to Article 4 of Decree 75/2016/ND-CP (amended in Decree 155/2018/ND-CP) are as follows:

* HIV screening tests conducted by the laboratories:

** Personnel:

There must be testers who:

- Have specialized high school diplomas or higher in one of the following majors: Medicine, Pharmacy, Biology or Chemistry.

- Are trained in HIV testing.

** The laboratory must have equipment used for testing and storing biologicals and specimens and is suitable to HIV testing techniques adopted by such laboratory.

** Facilities: There must be a permanent location.

* HIV screening tests in the community:

** The testers must have knowledge about counseling and HIV tests and shall conduct HIV tests in accordance with the instructions of the manufacturer.

** There must be equipment used for testing and storing biologicals and is suitable to the HIV biological being used.

2. Conditions to be satisfied by laboratories running confirmatory HIV tests in Vietnam

Conditions to be satisfied by laboratories running confirmatory HIV tests in Vietnam according to Article 5 of Decree 75/2016/ND-CP (amended in Decree 155/2018/ND-CP) are as follows:

* Personnel:

The chief technician must have at least a bachelor’s degree in medicine, pharmacy, biology or chemistry, as well as having experience in HIV testing for 06 months or above.

* Equipment requirements:

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

* The facilities must satisfy the following requirements:

- The materials in the testing area must be waterproof and resistant to high temperature and corrosive chemicals. The testing area must be sufficiently lighted, well-aired, clean, protected from dirt and humidity and must have clean water supply.

- Testing tables must be easily cleaned with common detergents, placed at sufficiently lighted and windless positions.

- Hand washing stations must be available.

- There must be equipment or methods for treating wastes before they are moved to the common garbage dump.

* A HIV testing laboratory must:

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

- At least 30 suspected HIV-positive samples are obtained during the period specified in Point a of Clause 4 Article 5 of Decree 75/2016/ND-CP (amended in Decree 155/2018/ND-CP). In case of testing by machine, a technique must be performed at least 20 times;

- Receive accurate testing results of reference samples from an HIV testing laboratory recognized by the Ministry of Health.

3. Regulations on suspension of HIV confirmatory tests in Vietnam

Regulations on suspension of HIV confirmatory tests under Article 12 of Decree 75/2016/ND-CP are as follows:

- HIV confirmatory tests shall be suspended in case of:

+ Failure to satisfy any of the conditions specified in Article 5 of Article 5 of Decree 75/2016/ND-CP (amended in Decree 155/2018/ND-CP); or

+ Failure to apply for adjustments to the certificate of eligibility in case of any changes specified in Clause 1 Article 11 of Decree 75/2016/ND-CP.

++ The name of the HIV testing laboratory is changed;

++ The person in charged is replaced;

++ The HIV testing technique is changed; or

++ Location of the laboratory is changed.

- During the inspection, if any of the violations specified in Clause 1 of Article 12 of Decree 75/2016/ND-CP is found, the inspectorate shall send a request for suspension of confirmatory HIV tests to the competent authority within 05 working days.

- 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.

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

- 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.

- If the laboratory fails to submit such report within the time limit specified in Clause 5 of Article 12 of Decree 75/2016/ND-CP or the rectification is not satisfactory, the competent authority shall revoke the certificate of eligibility.

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