Decree No. 75/2016/ND-CP on conditions for conducting HIV testing

DECREE

PROVISIONS ON CONDITIONS FOR IMPLEMENTING HIV TESTING

organization of the issued by the Government on June 19, 2015;

Pursuant to the Investment Law dated November 26, 2014;

Pursuant to the Law on Prevention and Control of Infection Caused by Viruses Leading to Acquired Immune Deficiency Syndrome (AIDS) numberissued on June 29, 2006, concerning persons infected with the virus causing human immunodeficiency syndrome (HIV/AIDS);

The Government promulgates this Decree stipulating the regulations on seniority allowances for teachers.Commended by the Minister of Health;

The Government issues this Decree to stipulate conditions for implementing HIV testing.This Decree stipulates conditions for implementing HIV testing (including screening HIV tests and confirmatory tests for HIV-positive cases); procedures for issuing, reissuing, revoking certificates of eligibility for conducting confirmatory tests for HIV-positive cases (hereinafter referred to as certificates of eligibility), and suspending activities of confirmatory tests for HIV-positive cases.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 2. Scope of Application

This Decree applies to organizations and individuals related to the implementation of HIV testing.The amount of fees collected for food safety and hygiene work shall be implemented according to the schedule of fees attached to this Circular.

1. Screening HIV tests involve performing a high-sensitivity HIV test technique using one type of HIV reagent with the aim of detecting potential HIV infections.

Article 3. Explanation of Terms

In this Decree, the following terms are understood as follows:

2. Confirmatory tests for HIV-positive cases involve performing HIV test techniques using three types of reagents with different principles or preparations to diagnose HIV infection in cases where the screening HIV test results are positive.

CONDITIONS FOR ESTABLISHMENTS IMPLEMENTING HIV TESTING

Chapter II

Article 4. Conditions for Establishments Implementing HIV Screening Tests

1. Personnel:There must be at least one laboratory technician meeting one of the following conditions:V

a) Holding a professional certificate within the scope of laboratory science;

b) Having been trained in HIV testing techniques.

2. Equipment for conducting and storing reagents and specimens must be suitable for the HIV testing techniques performed by the establishment.

3. Facilities must meet the minimum requirements as follows:

a) The testing area must use non-porous materials resistant to heat and corrosive chemicals, ensuring adequate lighting, ventilation, cleanliness, dust-free, moisture-proof, and access to clean water;

b) Laboratory tables must be easily cleaned with common cleaning agents, placed in well-lit areas away from drafts;

c) Handwashing facilities must be available;

d) Waste disposal methods or equipment must be in place before transferring waste to general waste containers.

Article 5. Conditions for Establishments Implementing Confirmatory Tests for HIV-Positive Cases

1. Professional staff must have a bachelor's degree or higher in medicine, pharmacy, biology, or chemistry, with at least 24 months of experience in laboratory techniques, including at least six months of HIV testing experience;

2. Directly involved technicians must have at least six months of experience in HIV testing techniques.3. Equipment must meet the minimum requirements as follows: a) Appropriate equipment for conducting and storing reagents and specimens must be available, suitable for the HIV testing techniques performed by the establishment;

a) Holding a professional certificate within the scope of laboratory science;

b) Equipment for storing specimens at temperatures of minus 20°C or lower must be provided.

4. Facilities must meet the minimum conditions specified in Clause 3 of Article 4 of this Decree.

5. Competence of establishments conducting HIV testing:

a) Must have at least three months of practical experience in conducting confirmatory HIV tests up to the date of submitting the application for recognition of eligibility to confirm HIV-positive test results;

b) During the period of practical experience in HIV testing as stipulated in point a of this clause, at least 30 suspected positive samples must be processed. In cases where machine-based testing is conducted, the technique must be performed at least 20 times;

c) Achieve satisfactory results in HIV testing competence verified by reference laboratories designated by the Ministry of Health or foreign reference laboratories recognized by the Ministry of Health (hereinafter referred to as Reference Laboratories). Verification of HIV testing competence includes:

- Results of 30 tests (20 positive and 10 negative) conducted independently by the establishment and confirmed by the Reference Laboratory to be identical;

- Accuracy of results from the quality control sample set sent by the Reference Laboratory for the establishment to test.

AUTHORITY, DOCUMENTATION, PROCEDURES FOR ISSUING, AMENDING, REVOKING CERTIFICATES OF ELIGIBILITY AND SUSPENDING ACTIVITIES OF CONFIRMATORY HIV-POSITIVE TEST RESULTS

c) Achieving the competency testing results for HIV testing confirmed by HIV reference laboratories designated by the Ministry of Health or foreign HIV laboratories recognized by the Ministry of Health (hereinafter referred to as HIV reference laboratories). The competency testing for HIV includes:

- The results of 30 samples (20 positive and 10 negative) conducted independently by the HIV testing facility and retested by the HIV reference laboratory are identical;

- The results of the quality control sample set sent by the HIV reference laboratory to the testing facility for analysis are accurate.

Chapter III

AUTHORITY, FILE, PROCEDURES FOR ISSUING, AMENDING, REVOKING THE CERTIFICATE OF QUALIFICATION AND SUSPENDING THE ACTIVITY OF CONFIRMATORY POSITIVE HIV TESTING RESULTS

Article 6. Authority to issue, adjust, revoke certificates of eligibility and suspend operations for confirming positive HIV test results

The Ministry of Health or agencies delegated or authorized by the Ministry of Health (hereinafter referred to as the competent authority) shall issue, adjust, revoke certificates of eligibility and suspend operations for confirming positive HIV cases at facilities conducting HIV tests.

Article 7. Forms of issuing certificates of eligibility1. Issuing new certificates of eligibility for facilities conducting HIV tests for the first time requesting such certificates.

2. Reissuing certificates of eligibility for facilities conducting HIV tests in any of the following cases:

a) The certificate is damaged or lost;

b) The laboratory confirmation certificate for HIV remains valid and was issued before this Decree.

Article 8. Documents for applying for new or reissued certificates of eligibility

1. Documents for applying for new certificates of eligibility include:

a) A new application form for a certificate of eligibility according to Form No. 01 stipulated in the Appendix attached to this Decree;

b) A list of personnel responsible for professional matters and those directly performing HIV testing techniques at the facility according to Form No. 04 stipulated in the Appendix attached to this Decree;

c) A list of equipment in the laboratory according to Form No. 05 stipulated in the Appendix attached to this Decree;

d) A floor plan of the testing area;

đ) A copy of the document confirming the results of HIV testing practice according to point c, Clause 4, Article 5 of this Decree.

2. Documents for applying for reissued certificates of eligibility: An application document for reissuing a certificate of eligibility according to Form No. 02 stipulated in the Appendix attached to this Decree.

Article 9. Procedures for issuing new certificates of eligibility

1. Testing facilities submit one set of application documents for a certificate of eligibility directly or through postal service to the competent authority as specified in Article 6 of this Decree.2. Within five working days from the date of receiving the documents, the competent authority sends a receipt for the application documents according to Form No. 06 stipulated in the Appendix attached to this Decree to the facility requesting the certificate of eligibility.3. In case the documents are not in compliance, within seven working days from the date recorded on the receipt, the competent authority must notify the facility requesting a new certificate of eligibility in writing to complete the documents. The notification specifies the details that need to be amended or supplemented. The facility requesting a new certificate of eligibility must amend or supplement the documents according to the contents stated in the notification and resubmit them to the competent authority.

4. If the documents are in compliance, the competent authority must conduct an assessment according to the provisions of Clause 5 of this Article within thirty days from the date recorded on the receipt.

5. Assessment procedures at HIV testing facilities

a) The competent authority establishes an assessment team comprising representatives of the competent authority, HIV testing experts, and other members when necessary;

b) The assessment team conducts inspections of conditions as stipulated in Article 5 of this Decree and specialized techniques according to guidelines of the Ministry of Health including: infrastructure, equipment, human resources, documentation, capability to perform HIV testing, sample management, biological material management, consumable supplies, and waste disposal;

c) Prepare an assessment report in four copies: two copies retained by the competent authority, one copy reported to the Ministry of Health, and one copy retained by the HIV testing facility.

6. Within ten days from the end of the assessment (the end of the assessment is calculated based on the date recorded on the assessment report), if the HIV testing facility meets the conditions for confirming positive HIV cases, the competent authority is responsible for issuing a certificate of eligibility according to Form No. 07 stipulated in the Appendix attached to this Decree.

7. Within ten days from the issuance of the certificate of eligibility, the competent authority publicly announces the HIV testing facility that has been granted the certificate of eligibility on its electronic information website.

8. The certificate of eligibility is issued once and has no expiration date.

6. Within ten days from the date of completion of the review (the date of completion of the review is calculated based on the date recorded in the review report), if the HIV testing facility meets the conditions for conducting confirmatory positive HIV testing, the competent authority shall be responsible for issuing the certificate of qualification according to Form No. 07 prescribed in the Appendix issued together with this Decree.

7. Within ten days from the date of issuance of the certificate of qualification, the competent authority shall publicly announce the HIV testing facilities that have been granted the certificate of qualification on the electronic information website of the competent authority.

8. The certificate of qualification is issued once and has no expiration date.

Article 10. Procedure for Reissuing the Certificate of Compliance

1. The HIV testing facility requesting reissue of the certificate of compliance shall submit the application to the competent authority.

2. Upon receipt of the application for reissuing the certificate of compliance, the competent authority shall send the Application Receipt Form according to Model No. 06 stipulated in the Appendix issued together with this Decree to the HIV testing facility requesting reissue of the certificate of compliance.

3. Within ten days from the date recorded on the Application Receipt Form, the competent authority shall issue the certificate of compliance.

Article 11. Amendment of the Certificate of Compliance

1. Cases for amending the certificate of compliance:

a) Change of name of the HIV testing facility;

b) Change of the person in charge of technical matters;

c) Change of HIV testing techniques;

d) Change of location of the HIV testing facility.

2. Application for amendment of the certificate of compliance shall be submitted to the competent authority:

a) For cases specified in point a or point d of Clause 1 of this Article, the application shall include: Request for amendment of the certificate of compliance according to Model No. 03 stipulated in the Appendix issued together with this Decree, certified copies of documents proving the change of name or location of the HIV testing facility;

b) For cases specified in point b of Clause 1 of this Article, the application shall include: Request for amendment of the certificate of compliance according to Model No. 03 stipulated in the Appendix issued together with this Decree, certified copies of relevant academic degrees, certificates, and professional qualifications of the person in charge of technical matters related to HIV testing;

c) For cases specified in point c of Clause 1 of this Article, the application shall include: Request for amendment of the certificate of compliance according to Model No. 03 stipulated in the Appendix issued together with this Decree, certified copies of confirmation of results of HIV testing samples conducted after changes in techniques as prescribed in point c of Clause 4 of Article 5 of this Decree.

3. Upon receipt of the application for amendment of the certificate of compliance, the competent authority shall send the Application Receipt Form according to Model No. 06 stipulated in the Appendix issued together with this Decree to the applicant.

4. In case the application is not valid, within ten days from the date recorded on the Application Receipt Form, the competent authority must notify the applicant in writing to complete the application. The notification shall specify the details of the required amendments and supplements. The applicant must amend and supplement the application according to the contents stated in the notification and resubmit it to the competent authority.

5. In case the application is valid, within fifteen days from the date recorded on the Application Receipt Form, the competent authority shall issue the amended certificate of compliance to the applicant. If the certificate is not issued, the competent authority must provide a written response stating the reasons.

Article 12. Suspension of Activities Confirming Positive HIV Test Results

1. Cases for suspension of activities:

a) Failure to meet one of the conditions prescribed in Article 5 of this Decree;

b) Failure to request amendment of the certificate of compliance when there is a change as prescribed in Clause 1 of Article 11 of this Decree.

2. During inspection and supervision of testing activities, if violations of the cases prescribed in Clause 1 of this Article are discovered, the inspection and supervision agency shall prepare a record of suspension of activities confirming positive HIV test results and report to the competent authority to issue a decision to suspend such activities within five working days.

3. Upon receipt of the suspension record, the testing facility shall immediately cease activities confirming positive HIV test results until receiving a formal suspension decision from the competent authority.

4. Within ten days from the date of receipt of the suspension record from the inspection and supervision agency, the competent authority shall review and issue a suspension decision.

5. Within six months from the date of issuance of the suspension decision, the HIV testing facility shall take corrective actions as required by the inspection and supervision agency. After completing the corrective actions, the testing facility shall report the results to the competent authority for consideration of allowing continued performance of confirmatory testing for HIV-positive cases.

6. If the HIV testing facility fails to report the results of corrective actions required by the inspection agency or if the corrective actions do not meet requirements within the time limit prescribed in Clause 5 of this Article, the competent authority shall revoke the certificate of compliance.

Article 13. Cases for Revocation of Certificates of Eligibility

1. Cases for Revocation of Certificates of Eligibility:

a) In case of violation as prescribed in Clause 6, Article 12 of this Decree;

b) Forgery of application documents for certificates of eligibility;

c) Renting, lending certificates of eligibility or arbitrarily modifying the contents of certificates of eligibility.

2. Procedures for Revoking Certificates of Eligibility

a) During inspection and supervision, if a testing facility violates the provisions set out in Point b or Point c, Clause 1 of this Article, the inspecting authority shall prepare a record to suspend HIV positive test result confirmation activities and send it to the competent authority;

b) Within ten days from the date of receipt of the suspension record as stipulated in Point a of this Clause, the competent authority shall examine and decide on the revocation of the certificate of eligibility;

c) In case of violation as prescribed in Point a, Clause 1 of this Article, the competent authority shall implement according to Clause 6, Article 12 of this Decree.

Chapter IV

RESPONSIBILITIES FOR IMPLEMENTATION

Article 14. Responsibilities of Testing Facilities for HIV

1. Conduct HIV tests in accordance with guidelines issued by the Ministry of Health.

2. Comply with regulations on inspection and supervision by competent authorities, provisions of this Decree, and other relevant laws.

3. Detect and report to competent authorities about substandard reagents and equipment used for HIV testing.

4. Cease HIV testing operations, notify relevant parties, and take measures to address and rectify when substandard quality testing is detected.

5. Other obligations as prescribed by law.

Article 15. Responsibilities of the Ministry of Health

1. Develop and promulgate legal documents governing HIV testing activities, development plans, and system planning for HIV testing facilities within its authority or submit them to competent authorities for issuance.

2. Direct, guide, publicize, and organize the implementation of legal documents guiding HIV testing activities, development plans, and system planning for HIV testing facilities.

3. Inspect, supervise, resolve complaints and grievances, and handle violations related to HIV testing.

4. Develop training programs and curricula, organize continuous training and capacity building for human resources, and research and apply science and technology in HIV testing.

5. Transfer files of HIV testing facilities that have been granted certificates of eligibility before the effective date of this Decree to authorized agencies as stipulated in Article 6 of this Decree.

6. Publish a list of reference HIV testing laboratories on the Ministry of Health's electronic portal.

Article 16. Responsibilities of the Provincial People's Committees

1. Direct and manage all activities related to HIV testing business operations in accordance with the law.

2. Inspect, supervise, resolve complaints and grievances, and handle violations related to HIV testing.

3. Direct specialized agencies to carry out procedures for issuing, adjusting, revoking certificates of eligibility, and suspending HIV positive test result confirmation activities for HIV testing facilities as delegated by the Ministry of Health.

Chapter V

IMPLEMENTING PROVISIONS

Article 17. Effective Date

This Decree takes effect from July 1, 2016.

Article 18. Transitional Provisionsn continue

HIV testing facilities that have been granted certificates of eligibility prior to the effective date of this Decree may continue their operations until the expiration of the certificate validity period. During this time, if there are adjustments to the certificate of eligibility, the HIV testing facility shall follow the adjustment procedures as prescribed in Article 11 of this Decree.

Upon expiration of the certificate validity period, the HIV testing facility shall follow the procedures for reissuing the certificate as prescribed in Article 10 of this Decree.

Article 19. Implementation

Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees directly under the Central Government shall be responsible for implementing this Decree.

 

 

ANNEX

(Attached to Decree No. 75/2016/NĐ-CP dated July 1, 2016 of the Government)

 

ModelType of mineral exported, quality

 

PETITION FOR APPLICATION

Issuance of New Certificate of Eligibility for Confirmatory HIV Positive Test Results

Respectfully submitted to: ...⁴………………..

Name of Requesting Authority: …

Address: …

Phone: …

Email (if any): ...

After studying Decree No.     /2016/NĐ-CP dated July 1, 2016 of the Government regarding conditions for conducting HIV tests, we request the authority to consider and proceed with the issuance of a new certificate of eligibility for confirming HIV positive test results using the … technique.⁵We hereby attach the following documents to this application:

 

______________________

¹ Name of requesting organization.

² Abbreviation of the name of the requesting organization.

³ Place name.

⁴ Name of the agency receiving the application.

⁵ List of HIV testing techniques applied at the facility.

 

Form No. 02

 

PETITION FOR APPLICATION

Reissuance of Certificate of Eligibility for Confirmatory HIV Positive Test Results

Respectfully submitted to: ...⁴…………………………….

Name of HIV Testing Facility: …

Address: …

Phone: …

Email (if any): ...

Certificate of Eligibility for Confirmatory HIV Positive Test Results No.: ……… Date of Issue: …Issued by …

Request for reissuance of certificate of eligibility due to … ⁵ ……………………………

We respectfully request the authority to consider and issue a new certificate of eligibility for confirming HIV positive test results./.

 

______________________

¹ Name of requesting organization.

² Abbreviation of the name of the requesting organization.

³ Place name.

⁴ Name of the agency receiving the application.

⁵ Lost, damaged, or expired certificate issued under Circular No. 15/2013/TT-BYT.

 

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives

 

PETITION FOR APPLICATION

Adjust the Certificate of Eligibility for Confirmatory Testing of HIV Positive Cases

Respectfully submitted to: ...⁴…………………………….

Name of HIV Testing Facility: …

Address: …

Phone: …Email (if any): …

Certificate of Eligibility for Confirmatory Testing of HIV Positive Results No.: ... Date of Issue: ... Issuing Authority: ...

Request to adjust the certificate of eligibility due to the reason:... ⁵ …………………

Attached documents:

We respectfully request the authority to consider and adjust the certificate of eligibility for the facility to confirm positive HIV test results.

 

______________________

¹ Name of requesting organization.

² Abbreviation of the name of the requesting organization.

³ Place name.

⁴ Name of the agency receiving the application.

⁵ List the reasons for requesting adjustment of the certificate.

 

ModelNumber 04

 

BẢN KÊ NHÂN SỰ XÉT NGHIỆM HIV CỦA CƠ SỞ XÉT NGHIỆM

 

______________________

¹ Name of requesting organization.

² Abbreviation of the name of the requesting organization.

³ Place name.

 

ModelNumber 05

 

LIST OF HIV TESTING EQUIPMENT OF THE TESTING FACILITY

 

______________________

¹ Name of requesting organization.

² Abbreviation of the name of the requesting organization.

³ Place name.

 

ModelNumber 06

 

1. Declaring entity:

Application file for issuing, reissuing, or adjusting the certificate of eligibility for confirmatory testing of HIV positive casesng recognition of qualification for testingm khẳng định các trường hợp HIV dương tính

Full name: …

Position: ...

Attended specialized training on... day... month... year:

The application file for ... has been received.⁴... requests issuance of the certificate of eligibility for confirmatory testing of HIV positive results of ...⁵including:

1. …………………………………⁶………………………………………………………………

2. ………………………………………………………………………………………………….

3. ………………………………………………………………………………………………….

4. ………………………………………………………………………………………………….

5. ………………………………………………………………………………………………….

 

 

______________________

¹ Name of the agency receiving the application.

² Abbreviation of the receiving authority.

³ Place name.

⁴ Clearly state the reason for submitting the application (New issue, reissue, adjustment).

⁵ Name of requesting organization.

⁶ List all documents included in the application.

 

ModelNumber 07

______________________

¹ State the name of the supervising authority (if any) and the name of the organization issuing the certificate.

² Abbreviation of the issuing authority of the certificate of eligibility.

³ Place name.

⁴ Write in uppercase letters, font size 14.

⁵ Address of the testing facility.

⁶ Clearly state the technique used for confirmatory HIV testing.

⁷ Ministry of Health, Proposing Organization, Electronic Portal of the Authority.