Thông tư 15/2013/TT-BYT bảo đảm chất lượng thực hiện kỹ thuật xét nghiệm HIV

THE MINISTRY OF HEALTH

Circular No. 15/2013/TT-BYT dated May 24, 2013 of the Ministry of Health on quality assurance and HIV testing technique

Pursuant to the Law on Prevention of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) dated June 29, 2006;

Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of Vietnam Administration of HIV/AIDS Control and the Director of the Legal Department;

The Ministry of Health issues a Circular on quality assurance and HIV testing techniques,

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular provides for:

1. The personnel, infrastructure, equipment, and control of testing quality of screening laboratories, confirmatory laboratories, and National Reference Laboratories (hereinafter referred to as HIV testing laboratories).

2. The procedure for announcing screening laboratories, accrediting confirmatory laboratories, and appointing National Reference Laboratories.

Article 2. Term interpretations

In this Circular, the terms below are construed as follows:

1.Screening laboratoriesare laboratories that implement one or multiple HIV testing techniques in accordance with Article 3 of this Circular, but are not allowed to confirm the positive result.

2.Confirmatory laboratoriesare screening laboratories that have been assessed and certified by the Ministry of Health to be eligible to confirm the confirmatory HIV test results.

3.National Reference Laboratoriesare confirmatory laboratories appointed by the Ministry of Health to perform the tasks in Article 28 of this Circular.

Article 3. Classification of HIV testing techniques

1. Serological HIV testing, including:

a) Testing for HIV by simple techniques without specialized testing equipment (hereinafter referred to as simple tests);

b) Testing for HIV by ELISA assays or chemiluminescence or electrochemiluminescence (hereinafter referred to as immunoblot techniques).

2. Testing for HIV by molecular biology techniques.

Chapter II

LABORATORY’S CONDITIONS PROVIDING SEROLOGICAL TESTS

Section 1. LABORATORY’S CONDITIONS PROVIDING SCREENING SEROLOGICAL TESTS

Article 4. Laboratory’s conditions performing simple tests

1. Personnel:

a) At least 02 laboratory technicians that:

- Hold intermediate qualifications in medicine, pharmacy, biology, or chemistry, or higher;

- Hold certificates of training in HIV testing issued by the medical facilities appointed by the Minister of Health, or certificates of training in HIV testing issued by foreign authorities that are suitable for the testing techniques they use.

b) At least 01 counselor meets the requirements in Clause 3 Article 26 of the Law on HIV/AIDS Prevention if blood specimens are taken and results are given to the persons being tested.

2. Infrastructure

Apart from satisfying the requirements of infrastructure in accordance with Clause 1 Article 55 of the Government s Decree No. 92/2010/ND-CP dated August 30, 2010 providing guidance on the implementation of the Law on HIV/AIDS prevention in terms of biosafety assurance of laboratories (hereinafter referred to as the Decree No. 92/2010/ND-CP), every laboratory that performs simple tests must satisfy the following requirements:

a) HIV testing areas must:

- Be separated from other testing areas in the laboratory;

- Be clean, ventilated, protected from dust and moisture;

- Have adequate electricity and clean water supply.

b) The testing table must be sufficiently lighted and put away from wind;

c) The walls of the testing area must be waterproof, able withstand heat and corrosive substances. The height from the tale surface must be at least 50 cm;

d) The sinks are located near the door of the testing room;

dd) Waste must be treated before being discharged into waste containers.

3. Equipment:

Apart from the requirements of equipment in Points b, c, and d Clause 2 Article 5 of the Decree No. 92/2010/ND-CP, every laboratory that performs simple tests must have:

a) Testing equipment suitable for the testing techniques being used;

b) Equipment to preserve bioproducts and specimens that are suitable for testing capacity;

c) Pipettes suitable for the testing techniques that use pipettes;

d) Stopwatches

4. Requirements for testing quality control:

a) Equipment of the laboratory must:

- Have documents for the equipment management, including: delivery notes, certificates of origins, logbooks, and instructions in Vietnamese;

- Have a summary of instructions stuck at convenient positions serving the use of the equipment;

- Be periodically maintained and fine-tuned;

- The temperature of freezers used for preserving specimens and bioproducts must be supervised every day be table or by book, and provided with backup power supply.

b) Comply with the instructions of the testing kits;

c) Participate in external quality assessment programs;

d) The HIV testing must meet the following requirements:

- Comply with the testing methods in Appendix 6 of the Circular No. 09/2012/TT-BYT dated May 24, 2012 of the Minister of Health providing guidance on epidemiological supervision of HIV/AIDS and supervision of sexually transmitted infections (hereinafter referred to as the Circular No. 09/2012/TT-BYT);

- Comply with the instructions of the testing kits.

dd) The HIV testing kits must have unexpired registration numbers, or be permitted by the Ministry of Health and unexpired.

e) Test results and the testing diagram shall be kept for 05 years from the testing date, applicable to all HIV testing techniques.

Article 5. Laboratory’s condition that implement immunoblot techniques

1. Personnel:

Apart from the requirements in Point b Clause 1 Article 4 of this Circular, every laboratory that implements immunoblot techniques shall have at least 02 laboratory technicians that:

a) Hold intermediate qualifications in medicine, pharmacy, biology, or chemistry, or higher qualifications. The laboratory manager must hold at least a bachelor’s degree;

b) Hold certificates of training in HIV testing issued by the medical facilities appointed by the Minister of Health, or certificates of training in HIV testing issued by foreign authorities that are suitable for the testing techniques they use.

2. Infrastructure:

Apart from the requirements in Point b Clause 2 Article 4 of this Circular, every laboratory that implements immunoblot techniques shall also have:

a) 01 deep sinks to wash the testing tools that are made of waterproof materials and able to withstand corrosive substances;

b) Air conditioners or dehumidifiers.

3. Equipment:

Apart from the requirements in Point b Clause 3 Article 4 of this Circular, every laboratory that implements immunoblot techniques shall also have:

a) One of the following systems: ELISA system, chemiluminescence system, or electrochemiluminescence;

b) At least 01 centrifuge suitable for the testing techniques;

c) At least 01 pipette kits suitable for the testing techniques.

4. Testing quality control: comply with the requirements in Clause 4 Article 4 of this Circular.

Section 2. LABORATORY CONDITIONS PROVIDING CONFIRMATORY SEROLOGICAL TESTS

Article 6. Personnel

Apart from the requirements in Point b Clause 1 Article 5 of this Circular, every confirmatory testing laboratory must satisfy the following requirements:

1. Testing personnel of the confirmatory laboratory must:

a) Have at least 01 year’s experience of HIV testing;

b) Have basic knowledge about HIV and HIV testing techniques, and able to analyze test results;

c) Be conversant with legislative documents relating to HIV testing.

2. The manager and personnel of the confirmatory laboratory must meet the requirements in Clause 3 Article 5 of the Decree No. 92/2010/ND-CP.

Article 7. Infrastructure

1. Meet the requirements of biosafety at level I in accordance with the Decree No. 92/2010/ND-CP and the requirements in Clause 2 Article 5 of this Circular. Confirmatory laboratories doing animal testing must meet level III of biosafety in accordance with the Decree No. 92/2010/ND-CP.

2. Have backup power supplies.

Article 8. Equipment

Apart from the requirements of equipment in Points b, c, and d Clause 2 Article 5 of the Decree No. 92/2010/ND-CP, every serological laboratory must:

1. The equipment is suitable for the HIV testing techniques being used in accordance with Section 1 Chapter II of this Circular.

2. A freezer at least -20 oC to store the specimens that have positive or indeterminate results.

Article 9. Quality control’s requirements

Testing quality control: comply with the requirements in Clause 4 Article 4 of this Circular.

Article 10. HIV testing capability’s requirements

1. Requirements of experience of HIV testing:

a) Have been doing HIV tests using method III in Appendix 6 to the Circular No. 09/2012/TT-BYT at least 3 months before the application for the accreditation of eligibility to confirm positive results is submitted;.

b) At least 50 test results are positive during the period of HIV testing stated in Point a Clause 1 of this Article. At least 20 tests by immunoblot techniques are performed;

c) Results of test verifications are satisfactory.

2. Participate in external quality assessment programs. The results of 02 latest assessments must be satisfactory.

3. The specimens that have positive and indeterminate results must be scientifically, rationally, and sufficiently stored during the testing period specified in Point a Clause 1 of this Article.

Section 3. CONDITIONS FOR NATIONAL SEROLOGICAL REFERENCE LABORATORIES

Article 11. Personnel

Apart from the requirements in Clause 3 Article 6 of this the Decree No. 92/2010/ND-CP and Clause 1 Article 6 of this Circular, every National Laboratory for serological HIV testing shall have at least 08 employees, including:

1. Two managers that hold bachelor’s degrees in medicine or biology and have at least 05 years’ experience of serological HIV testing.

2. The employees in charge of testing quality control, formulating standards, and biosafety must hold bachelor’s degrees in medicine or biology and have at least 03 years’ experience of serological HIV testing.

3. Other employees must have qualifications suitable for their tasks and have at least one year’s experience of such tasks.

Article 12. Infrastructure

Comply with the requirements in Clause 1 Article 6 of the Decree No. 92/2010/ND-CP.

Article 13. Equipment

Apart from the requirements of equipment in Clause 2 Article 6 of the Decree No. 92/2010/ND-CP, every National Reference Laboratory for serological HIV testing must also:

1. Have sufficient fundamental testing equipment, in particular:

a) 02 ELISA kits, including 01 automatic ELISA kit and 01 semi-automatic ELISA kit;

- 01 3-D shakers to do Western Blot tests;

- 01 high-speed centrifuge (at least 15,000 rounds per minute);

- 02 magnetic stirrers;

- 02 mixers;

- 02 pipette kits suitable for the testing techniques.

- 01 deep freezer at 20oC to store specimens and chemicals serving the production of specimens for external and internal quality assessment;

- 01 deep freezer at 70oC to store samples serving the establishment of HIV sample banks;

- 03 freezers at 04 - 08oC. 01 freezer is for storing bioproducts, 01 deep freezer for storing specimens; and 01 freezer serving the production of specimens for external quality assessment;

- 01 incubator at 37oC;

- 01 heated bath;

- 01 vacuum pump;

- 01 laboratory label printer.

b) Other equipment and consumables that are suitable for the testing techniques being used at the laboratory.

Article 14. Conditions for quality control and capacity HIV testing

1. Requirements for testing quality control: ISO 15189 or the equivalent applicable to laboratories. The production and supply of specimens for external and internal quality assessment must comply with ISO 17043.

2. Requirement of capacity for HIV testing:

a) Able to manage and provide external and internal quality assessment programs for other serological laboratories;

b) Able to support the formulation of standards procedures for HIV serological testing as reference for serological laboratories;

c) Able to devise methods of HIV serological testing and provide training in serological HIV testing;

d) Having a sample bank service the HIV testing quality assurance;

dd) Able to cooperate or organize scientific researches relating to biology, pathology, and immunology; assess the methods of serological HIV testing, quality of bioproducts for serological testing, and do other relevant researches

e) Able to perform all serological HIV testing techniques and do tests to confirm the HIV infection of indeterminate results.

c) Participate in annual external quality assessment programs of international organizations and agencies accredited by the Ministry of Health.

Chapter III

LABORATORY’S REQUIREMENTS PERFORMING MOLECULAR BIOLOGY TESTS

Article 15. Laboratory’s requirements that perform molecular biology tests

1. Personnel:

Apart form the requirements in Clause 3 Article 6 of the Decree No. 92/2010/ND-CP and Point b Clause 1 Article 4 of this Circular, every laboratory that performs molecular biology tests must have at least 02 employees that:

a) Hold intermediate qualifications in medicine, pharmacy, biology, or chemistry, or higher qualifications. The manager of the laboratory must hold at least a bachelor’s degree in medicine or biology;

b) Hold certificates of training in molecular biology testing issued by the medical facilities appointed by the Minister of Health, or certificates of training in HIV testing issued by foreign authorities that are suitable for the testing techniques they use.

c) Have at least 01 year’s experience of molecular biology testing.

2. Infrastructure:

Apart from the requirements in Clause 1 Article 6 of the Decree No. 92/2010/ND-CP, laboratories that perform molecular biology tests must also satisfy the following conditions:

a) The laboratories that use non-automated testing system, which is not completely closed, must have at least 03 separate areas that are designed in the following order.

- Chemical preparation room;

- Specimen preparation room;

- Amplification room.

Every laboratory that performs PCR testing must have a separate room or area to analyze PCR products.

b) The designs of laboratories that use automated and closed testing system must be conformable with the requirements for the entire system.

3. Equipment:

Apart from the requirements in Clause 2 Article 6 of the Decree No. 92/2010/ND-CP, every laboratory that performs molecular biology tests must have:

a) The equipment suitable for the testing techniques being used, in particular:

- In the chemical preparation room:

+ Freezer at 4ºC and -20ºC to preserve chemicals and bioproducts;

+ Biosafety cabinets or PRC cabinets with UV lamps and lights;

+ Centrifuge used for test tubes from 1.5 – 2 ml;

+ Mixer-shaker;

+ Pipette kits used for making reactive solutions.

- Specimen preparation room (RNA/DNA extraction):

+ Biosafety cabinet level II;

+ Freezer -80ºC;

+ Freezer -4ºC;

+ A Centrifuge used for test tubes from 2 – 5 ml;

+ Mixer-shaker;

+ Pipette kits used for extraction;

+ Timer;

+ Mixer, incubation (depending on technical requirements);

+ Machines used to prepare samples for processing and extraction (if any).

- Amplification room:

+ Thermalcycler when using ordinary molecular biology testing machines or Real Time PCR;

+ Centrifuge used for test tubes from 0.2 – 2 ml;

+ Pipette kits suitable for every technique;

+ PCR cabinets;

+ Freezer 4oC to store molecular biology products

b) The following equipment is necessary for PCR testing at PCR analysis areas:

- Electrophoresis system, gel analyzer or ELISA kits when analyzing results by ELISA techniques;

- + Separate pipette kits;

- + freezer 4ºC;

c) Consumables used for testing that are suitable for the molecular biology techniques.

4. Requirements of quality control:

Satisfy the requirements of quality control in Points a, b, c, dd and e Clause 4 Article 4 of this Circular.

5. The laboratories that perform molecular biology tests on children under 18 months of age must satisfy the following requirements:

a) Requirement of capacity for HIV testing:

- Have been performing molecular biology tests for at least 06 months before the application is submitted and at least 20 test results are indeterminate;

- c) Results of test verifications are satisfactory.

b) The specimens that have positive and indeterminate results must be scientifically, rationally, and sufficiently stored during the testing period specified in Point a of this Clause.

Article 16. Requirements for National Reference Laboratory on molecular biology HIV testing

1. Personnel:

Apart from the requirements in Clause 3 Article 6 of this the Decree No. 92/2010/ND-CP and Point b Clause 1 Article 4 of this Circular, every national laboratory must have at least 05 employees, including:

a) A manager holding a doctorate degree in medicine or biology, and have at least 05 years’ experience of HIV testing by molecular biology techniques;

b) The employees in charge of quality control, biosafety and making standard samples must hold bachelor’s degrees in medicine or biology and have at least 03 years’ practical experience of molecular biology testing;

c) Other employees must have appropriate qualifications and at least 01 year’s experience of the assigned tasks.

2. Infrastructure: satisfy the requirements in Clause 2 Article 15 of this Circular.

3. Equipment: satisfy the requirements in Clause 3 Article 15 of this Circular.

4. Requirements for quality control: ISO 15189 or the equivalent applicable to laboratories. The production and supply of specimens for external and internal quality assessment must comply with ISO 17043.

5. Requirement of capacity for HIV testing:

a) Able to manage and provide external and internal quality assessment programs for other laboratories that perform molecular biology tests;

b) Able to formulate of standards procedures for molecular biology testing as reference for laboratories that perform molecular biology tests;

c) Able to provide training in molecular biology testing;

d) Able to cooperate or organize scientific researches related to biology, pathology, and molecular biology relating to HIV and relevant researches;

dd) Able to perform all kinds of molecular biology tests.

e) Participate in annual external quality assessment programs carried out by reputable international organizations.

Chapter IV

DOCUMENTATION, PROCEDURE, AND AUTHORITY TO ACCREDIT HIV TESTING LABORATORIES

Section 1. Procedure for accrediting screening laboratories

Article 17. Application for accreditation of eligibility to perform screening tests

1. A written request for the accreditation of eligibility to perform screening HIV tests in accordance with the form in Appendix 1 to this Circular.

2. A certified true copy of the operation license issued to the private medical facility by competent authorities, or a copy of the Decision on Establishment issued by competent authorities to the state medical facility.

3. A list of personnel of the laboratory in accordance with Appendix 2 to this Circular. The laboratories affiliated to medical facilities must send certified true copies of the practice certificates of their personnel.

4. A manifest of infrastructure enclosed with the site plan of the laboratory, which bear the stamp of the facilities and the signature of the Director.

5. A manifest of equipment of the laboratory in accordance with Appendix 3 to this Circular.

Article 18. Procedure for accrediting screening laboratories

1. The procedure for certifying the eligibility to perform HIV testing applicable to the laboratories affiliated to medical facilities: the procedure for accrediting the eligibility to perform HIV testing must be done concurrently with the submission of the application for the operation license.

2. The procedure for accrediting the eligibility to perform HIV testing applicable to laboratories not affiliated to medical facilities:

a) Before doing HIV screening tests, any facility that have a HIV testing laboratory shall send 01 dossier specified in Article 17 of this Circular to the local Service of Health;

b) After the dossier is received, the Service of Health shall send an notice of receipt of the dossier in accordance with the form in Appendix 4 to this Circular;

c) If the Service of Health does not request any amendments to the dossier after 15 working days from date on the notice of receipt, the facility may commence the HIV testing;

d) If the dossier is not valid, the Service of Health shall send a written request for the amendments within 05 working days from the day on which the dossier is received. The application for the amendments must specify the documents and information that need amending;

dd) After receiving the request for amendments, the facility shall make amendments in accordance with the request, and send the amended dossier to the Service of Health;

e) If the Service of Health does not request any amendments to the dossier after 15 working days from the date on the notice of receipt of the amended dossier, the facility may commence the HIV testing.

Section 2. DOCUMENTATION AND PROCEDURE FOR ISSUING AND REISSUING THE CERTIFICATE OF CONFIRMATORY LABORATORY

Article 19. Documentation and procedure for the new issuance of the certificate of confirmatory laboratory

1. The application for the new issuance of the certificate of confirmatory laboratory are specified in Article 17 of this Circular.

2. The procedure for the new issuance of the certificate of confirmatory laboratory:

a) The facility that has the laboratory (hereinafter referred to as the applicant) shall send 01 application to Vietnam Administration of HIV/AIDS Control – the Ministry of Health. The receipt date of the application is the date on the date stamp of Vietnam Administration of HIV/AIDS Control;

b) Within 05 working days from the day on which the dossier is received, if no request for the amendments to the application is made, Vietnam Administration of HIV/AIDS Control shall appoint an agency to inspect and assess the capacity for HIV testing (hereinafter referred to as inspecting agency) of the applicant;

c) If the application is not valid, within 05 working days from the day on which the application is received, Vietnam Administration of HIV/AIDS Control shall send the applicant a written request for amendments to the application. The request must specify the documents and information that need amending;

d) The applicant shall make amendments in accordance with such request and send the application to Vietnam Administration of HIV/AIDS Control. The receipt date of the amended application is the date on the date stamp of Vietnam Administration of HIV/AIDS Control. If the amended application is valid, the Ministry of Health shall appoint an inspecting agency within 05 working days from the day on which the amended is received;

dd) If the amendments are not conformable with the request, Vietnam Administration of HIV/AIDS Control shall request the applicant to amend the application in accordance with Points c and d of this Clause.

3. Inspecting the capacity for HIV testing of the applicant:

a) Within 10 working days from the day on which the written appointment is made by Vietnam Administration of HIV/AIDS Control, the inspecting agency shall send the applicant the assessment and report forms serving the inspection of capacity for HIV testing;

b) Within 20 days from the day on which such forms are received, the applicant shall make and send a report on its capacity for HIV testing to the inspecting agency, including:

- The test results and 30 consecutive specimens done by the applicant (including 20 specimens that have positive results by method III, and 10 specimens that have negative results), applicable to serological laboratories;

- The test results on the assessment forms sent the inspecting agency:

b) Within 10 days from the day on which the report sent by the applicant is received, the inspecting agency shall assess the capacity for testing based on:

- The specimens sent by the applicant;

- The result of the assessment forms sent by the inspecting agency;

After the assessment is finished, the inspecting agency shall send the result to the Vietnam Administration of HIV/AIDS Control in accordance with the form in Appendix 5 to this Circular;

d) Within 10 working days from the day on which the report sent by the inspecting agency is received (in accordance with the date stamp of the Vietnam Administration of HIV/AIDS Control), Vietnam Administration of HIV/AIDS Control shall:

- Request the Minister of Health to consider establishing a field inspectorate if the inspection result is satisfactory;

- Send written notification of the unsatisfactory result to the applicant.

4. Assessment serving the new issuance of the certificate of confirmatory laboratory:

a) The Minister of Health shall establish an inspectorate, which consists of:

- The Chief Inspector, being the representative of Vietnam Administration of HIV/AIDS Control;

-  Representatives of the Legal Department;

-  Representatives of the National Reference Laboratory of serological HIV testing;

- Independent experts in HIV testing;

-  Experts from Vietnam Administration of HIV/AIDS Control as the secretary.

b) Associates during the inspection:

- Representatives of Institute of Hygiene and Epidemiology, Pasteur Institute of Ho Chi Minh City, Pasteur Institute of Nha Trang, or Institute of Hygiene and Epidemiology of Tay Nguyen (hereinafter referred to as local Institute), depending on the locality where the applicant is situated.

- Representatives of the local Service of Health.

c) Procedure for the assessment serving the new issuance of the certificate of confirmatory laboratory:

- Inspect the legal documents; inspect the infrastructure, equipment, and personnel of the applicant;

- Make an inspection record in accordance with the form in Appendix 6 in accordance with this Circular;

- The inspection record shall be made into 05 copies: 01 copy is kept at the Vietnam Administration of HIV/AIDS Control - the Ministry of Health, 01 copy is kept at the National Reference Laboratory for serological HIV testing, 01 is kept at the local institute, and 01 copy is kept at the inspected facility;

- Within 05 working days from the end of the inspection, Vietnam Administration of HIV/AIDS Control shall request the Ministry to consider issuing the Certificate of confirmatory laboratory in accordance with the form in Appendix 7 to this Circular. The refusal to issue must be notified and explained in written form.

5. Management of certificates of confirmatory laboratory:

a) Each confirmatory laboratory shall be issued with only one certificate of confirmatory laboratory, which is valid for 05 years from the issuance date;

b) The copies of the certificate of confirmatory laboratory, applications for new issuance and re-issuance of the certificate of confirmatory laboratory shall be kept by the issuing authorities;

c) After a certificate of confirmatory laboratory is issued, the Ministry of Health shall send a written notification to the provincial People’s Committees and the local Service of Health within 03 days from the issuance date.

Article 20. Documentation and procedure for reissuing the certificate of confirmatory laboratory

1. The certificate shall be reissued in the following cases:

a) The certificate expires;

b) The certificate is lost or damaged;

c) The manager or testing personnel are replaced;

d) The location of the laboratory is changed;

dd) New HIV testing techniques are provided;

e) The certificate is revoked.

2. Documentation and procedure for reissuing the certificate of confirmatory laboratory when it is lost or damaged:

a) The application for the re-issuance of the certificate of confirmatory laboratory includes:

- The written request for the re-issuance in accordance with the form in Appendix 8 to this Circular;

- The issued certificate of confirmatory laboratory (if any).

b) Inspection serving the re-issuance of the lost or damaged certificate of confirmatory laboratory:

- Inspect the inspection record stored at the Ministry of Health or the damaged certificate of confirmatory laboratory (if any);

- Within 05 working days from the day on which the application is received, Vietnam Administration of HIV/AIDS Control shall request the Minister of Health to consider reissuing the certificate of confirmatory laboratory.

3. Documentation and procedure for reissuing the certificate of confirmatory laboratory when the manager or testing personnel are replaced, or when the location of the laboratory is changed:

a) The application for the new issuance of the certificate of confirmatory laboratory: follow Point a Clause 2 Article 2 of this Circular;

b) The inspection serving the re-issuance of the certificate of confirmatory laboratory when the manager or testing personnel are replaced, or when the location of the laboratory is changed:

- Vietnam Administration of HIV/AIDS Control shall appoint an inspecting agency to carry out a field inspection within 05 working days from the day on which the dossier is received;

- The inspecting agency shall inspect the testing techniques at the applying laboratory within 15 working days and send a report to Vietnam Administration of HIV/AIDS Control together with an inspection record;

- Within 10 working days from day on which the inspection record sent by the inspecting agency, Vietnam Administration of HIV/AIDS Control shall request the Minister of Health to consider reissuing the Certificate of confirmatory laboratory in accordance with the form in Appendix 7 to this Circular.

4. For the cases in Point a, Point dd, and Point e Clause 1 of this Article, the procedure is similar to that in Article 19 of this Circular.

Section 3. AUTHORITY, DOCUMENTATION, AND PROCEDURE FOR APPOINTING NATIONAL REFERENCE LABORATORIES

Article 21. Appointment authority to the National Reference Laboratory

The Minister of Health shall appoint HIV testing laboratories belong to the state health system as National Reference Laboratories.

Article 22. Appointment procedure to National Reference Laboratories

1. Vietnam Administration of HIV/AIDS Control shall request the potential Reference Laboratories (hereinafter referred to as candidates) to make an application that consists of the papers specified in Clauses 2, 3, 5, and 5 Article 17 of this Circular to the Ministry of Health.

2. Procedure for processing the application:

a) Within 10 working days from the day on which the application is received, if no request for additional documents is made, Vietnam Administration of HIV/AIDS Control shall request the Minister of Health in writing to consider establishing an inspectorate;

b) If the application is not valid, within 05 working days from the day on which the application is received, Vietnam Administration of HIV/AIDS Control shall send the candidate a written request for amendments to the application. The request must specify the documents and information that need amending;

c) Within 20 days from the day on which the request is received, the candidate shall make amendments in accordance with such request and send the application to Vietnam Administration of HIV/AIDS Control. The receipt date of the amended application is the date on the date stamp of Vietnam Administration of HIV/AIDS Control.

If the amended application is valid, the Ministry of Health shall make a request for the establishment of an inspectorate within 05 working days from the day on which the amended is received in accordance with Point a of this Clause;

d) If the amendments are not conformable with the request, Vietnam Administration of HIV/AIDS Control shall request the intended laboratory to amend the application in accordance with Points b and c of this Clause.

3. Inspection:

a) The Minister of Health shall establish an inspectorate, which consists of:

- The Chief Inspector, being the representative of Vietnam Administration of HIV/AIDS Control;

- Independent experts in HIV testing; biosafety; HIV testing quality assurance;

- Representatives of the Legal Department – the Ministry of Health;

- Representatives of the Department of Medical Examination and Treatment – The Ministry of Health;

- Representatives of the Department of Defensive Medicine – The Ministry of Health;

- An expert from Vietnam Administration of HIV/AIDS Control as the secretary.

b) Inspection procedure: follow the procedure in Point c Clause 4 Article 19 of this Circular.

Section 4. SUSPENSION FOR HIV TESTING, REVOKE OF CONFIRMATORY LABORATORY CERTIFICATES

Article 23. Suspension cases for HIV testing laboratories

An HIV testing laboratory shall be suspended in the following cases:

1. It fails to comply with the testing procedures or commit technical errors in accordance with technical instructions provided by the Minister of Health without affecting the test results.

2. It does not have sufficient devices for testing, or the testing devices are not functional or substandard.

3. It fails to participate in external quality assessment programs.

4. Its infrastructure fails to meet the requirements in this Circular.

5. It fails to record and report HIV test results.

Article 24. Suspension authority

1. The Minister of Health shall decide the suspension of confirmatory HIV testing laboratories and National Reference Laboratories.

2. Directors of provincial Services of Health shall decide the suspension of screening laboratories.

Article 25. Suspension procedure and time

1. During the inspection, if the laboratory is discovered violating one of the regulations in Article 23 of this Circular, the inspecting agency shall make a record on the suspension in accordance with the form in Appendix 9 to this Circular and send it to Vietnam Administration of HIV/AIDS Control or the Medical Technique Department – Service of Health.

2. Within 05 working days from the day on which the record on the suspension is received:

a) Vietnam Administration of HIV/AIDS Control shall request the Minister of Health to consider imposing the suspension;

b) The Medical Technique Department shall request the Director of the provincial Service of Health to impose the suspension.

3. The decision on suspension is valid for 06 months from the date on which it is signed and issued. The decision shall be sent as follows:

a) For confirmatory laboratories and National Reference Laboratories: the medical facility that have the suspended HIV testing laboratory and the units participated in the inspection serving the issuance of the certificate of confirmatory laboratory or the appointment of National Reference Laboratory;

b) For screening laboratory: the facility that has the suspended HIV testing laboratory and the provincial HIV/AIDS Control Center.

4. If the suspended HIV testing laboratory has rectified the errors, at least 30 days before the decision on suspension expires, the report on rectification must be sent to:

a) The inspecting agency in accordance with Point b Clause 2 Article 19 of this Circular, applicable to confirmatory laboratory and National Reference Laboratories;

b) The HIV/AIDS Control Center of the province where the suspended HIV testing laboratory is located, applicable to screening laboratories;

c) The date of receipt of the rectification report is identified based on the date stamp of the agencies mentioned in Point a and Point b of this Clause.

5. Within 20 working days from the day on which the rectification report is received, the unit mentioned in Point a and Point b Clause 3 of this Article shall carry out an inspection an report the inspection result to Vietnam Administration of HIV/AIDS Control – the Ministry of Health or the Medical Technique Department – Service of Health. The date of receipt of the rectification report is identified based on the date stamp of Vietnam Administration of HIV/AIDS Control or the provincial Service of Health.

6. If the suspended laboratory has rectified the errors and met the requirements in this Circular, within 05 working days from the day on which the reports sent by the units mentioned in Clause 3 of this Article:

a) Vietnam Administration of HIV/AIDS Control shall request the Minister of Health to consider terminating the suspension. The decision to terminate the suspension shall be sent to the medical facility that have the suspended HIV testing laboratory and the units participated in the inspection serving the issuance of the certificate of confirmatory laboratory or the appointment of National Reference Laboratory;

b) The Medical Technique Department shall request the Director of the provincial Service of Health to consider terminating the suspension. The decision on terminating the suspension shall be sent to the facility that has the suspended HIV testing laboratory and the provincial HIV/AIDS Control Center.

7. If the suspended laboratory fails to rectified the errors or the rectification fails to meet the requirements of this Circular at the end of the suspension period, within 05 working days from the expiration date of the suspension or the date on which the report sent by the unit mentioned in Clause 3 of this Article is received:

a) Vietnam Administration of HIV/AIDS Control shall request the Minister of Health to consider revoking the certificate of confirmatory laboratory or the decision to appoint the National Reference Laboratory;

b) The Medical Technique Department shall request the Director of the provincial Service of Health to consider terminating operation of the facility.

Article 26. Revoke of confirmatory laboratory certificate and the decision to appoint a National Reference Laboratory

1. A certificate of confirmatory laboratory or a decision to appoint a National Reference Laboratory shall be revoked in the following cases:

a) The cases in Clause 7 Article 25 of this Circular;

b) The certificate of confirmatory laboratory or the decision to appoint National Reference Laboratory is issued ultravires, or its contents are unlawful;

c) The laboratory is no longer functional, is bankrupt, dissolved, or merged into another organization;

d) The laboratory has its operation license revoked under the decision of a competent authority.

dd) The bioproducts used for HIV testing are not registered or not permitted by the Ministry of Health or expired.

2. The Minister of Health shall decide the revocation of certificates of confirmatory laboratory and decisions to appoint National Reference Laboratories.

3. The procedure for revoking the certificate of confirmatory laboratory or the decision to appoint the National Reference Laboratory:

a) During the inspection, if the laboratory is discovered violating one of the regulations in Article 1 of this Circular, the inspecting agency shall make a suspension record in accordance with the form in Appendix 9 to this Circular and send it to Vietnam Administration of HIV/AIDS Control;

b) Within 05 working days from the day on which the suspension record mentioned in Clause 1 of this Article is received, the Vietnam Administration of HIV/AIDS Control – the Ministry of Health shall request the Minister of Health to consider revoking the certificate of confirmatory laboratory or the decision to appoint the National Reference Laboratory;

c) The decision to revoke the certificate of confirmatory laboratory or the decision on National Reference Laboratory appointment shall be sent to:

- The HIV testing laboratory that has its certificate of confirmatory laboratory or the decision to appoint a National Reference Laboratory revoked;

- The units participating in the inspection serving the issuance of the certificate of confirmatory laboratory or the decision to appoint a National Reference Laboratory.

Chapter V

IMPLEMENTATION RESPONSIBILITIES

Article 27. HIV testing laboratory’s obligations

1. Obligations of screening laboratory:

a) Take or receive specimens to perform HIV testing; do not confirm positive results;

b) Participate in external quality assessment programs approved or appointed by the Ministry of Health;

c) Provide counseling and HIV testing; notify HIV test results in accordance with the Law on HIV/AIDS prevention;

d) Make reports in accordance with the Circular No. 09/2012/TT-BYT, record and keep testing books in accordance with the Decision No. 868/QD-BYT dated March 29, 2005 of the Minister of Health on the promulgation of 07 forms used for HIV testing laboratories.

2. Obligations of confirmatory laboratories:

Apart from the obligations in Clause 1 of this Article, confirmatory laboratories are also obliged to:

a) Receive specimens that have indeterminate results from screening laboratories in the same or adjacent localities to test and confirm. Specimens that have positive or indeterminate results shall be kept for 02 years from the testing date;

b) Provide training, technical assistance, and carry out inspections once a year at local screening laboratories.

Article 28. National Reference Laboratory’s obligations

Apart from the obligations in Clause 2 of Article 27 of this Circular, National Reference Laboratories are also obliged to:

1. Receive specimens that have indeterminate results sent by confirmatory laboratories.

2. Provide training, technical assistance; carry out periodic inspections once year at confirmatory laboratory under the arrangement of the Ministry of Health.

3. Ensure the quality of the system of HIV testing laboratories.

Article 29. Obligations of Vietnam Administration of HIV/AIDS Control – the Ministry of Health

1. Provide guidance, supervise and assess the operation and HIV test results of HIV testing laboratories nationwide.

2. Direct National Reference Laboratories to formulate documents and provide training in HIV testing for local units.

3. Hold annual conferences on assessment and implementation HIV testing quality assurance.

Article 30. Obligations of provincial Departments of Health 

1. Provide guidance and inspect the HIV testing works locally.

2. Suggest changes to rectify the absurdities related to the HIV testing quality assurance during the implementation of this Circular.

3. Cooperate with agencies concerned in supporting and supervising HIV testing.

4. Send the list of local confirmatory laboratories and screening laboratories to the Ministry of Health.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 31. Transitional provisions

1. The HIV testing laboratories that are established or upgraded after this Circular takes effect must comply with this Circular.

2. The HIV testing laboratories that have operated before this Circular takes effect must make plans for upgrade and meet the requirements in this Circular by December 31, 2014.

3. The screening laboratories affiliated to the medical facilities that are established before this Circular takes effect may carry on their operation and announce their eligibility to perform HIV testing by December 01, 2013 in accordance with Clause 2 Article 18 of this Circular.

4. The confirmatory laboratories certified by the Ministry of Health before this Circular takes effect may carry on their operation and send the papers in Clause 17 of this Circular together with the annual inspection records to Vietnam Administration of HIV/AIDS Control – the Ministry of Health for assessment.

If the HIV testing laboratory meets the requirements in this Circular, Vietnam Administration of HIV/AIDS Control shall request the Ministry of Health to consider issuing the certificate of confirmatory laboratory.

If the HIV testing laboratory fails to meet the requirements in this Circular, Vietnam Administration of HIV/AIDS Control shall request the Ministry of Health to consider revoking the decision to certify the eligibility to confirm positive test results that was issued.

Article 32. Terms for reference

When the documents referred to in this Circular are amended or superseded, the new or amended documents shall apply.

Article 33. Effects

1. This Circular takes effect on July 01, 2013.

2. The Decision No. 3052/2000/QD-BYT dated August 29, 2000 of the Minister of Health promulgating standards of confirmatory laboratories are annulled on the effective date of this Circular.

Article 34. Implementation responsibilities

Chief of the Ministry Office, the Director of Vietnam Administration of HIV/AIDS Control, the Directors of other Departments affiliated to the Ministry of Health, Directors of agencies affiliated to the Ministry, Directors of provincial Services of Health, Directors of ministerial health of other Ministries are responsible for the implementation of this Circular.

The difficulties arising during the course of implementation should be reported to the Ministry of Finance for consideration and settlement./.

For the Minister of Health

Deputy Minister

Nguyen Thanh Long