Circular No. 15/2013/TT-BYT guiding the assurance of quality in implementing HIV testing techniques

 

CIRCULAR

GUIDELINES FOR ENSURING THE QUALITY OF HIV TESTING TECHNIQUES IMPLEMENTATION

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Pursuant to the Law on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (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 the Circular guiding the assurance of quality for the implementation of HIV testing techniques.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates the following matters:

1. Conditions regarding personnel, infrastructure, equipment, and quality management of HIV testing for HIV screening laboratories, HIV confirmatory laboratories, and the national reference laboratory for HIV testing (hereinafter collectively referred to as HIV testing laboratories).

2. Procedures for announcing HIV screening laboratories, recognizing HIV confirmatory laboratories, and designating the national reference laboratory for HIV testing.

Article 2. Interpretation of Terms

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

1. An HIV screening laboratory is a laboratory that performs one or more HIV testing techniques specified in Article 3 of this Circular but does not confirm positive HIV cases.

2. An HIV confirmatory laboratory is an HIV screening laboratory that has been reviewed and recognized by the Ministry of Health as meeting the conditions to confirm HIV confirmatory test results.

3. The national reference laboratory for HIV testing is an HIV confirmatory laboratory designated by the Ministry of Health to perform tasks specified in Article 28 of this Circular.

Article 3. Classification of HIV Testing Techniques

1. Serological HIV testing, including:

a) Simple HIV testing technique that does not require specialized testing equipment (hereinafter referred to as simple HIV testing technique);

b) HIV testing using ELISA, chemiluminescence, or electrochemiluminescence techniques (hereinafter referred to as HIV testing using immunological marker techniques).

2. Molecular biology HIV testing.

Chapter II

Article 4. CONDITIONS FOR HIV TESTING LABORATORIES USING SEROLOGICAL TECHNIQUES

Section 1. CONDITIONS FOR HIV SCREENING LABORATORIES USING SEROLOGICAL TECHNIQUES

Article 4. Conditions for HIV testing laboratories using simple techniques

1. Personnel Conditions:

a) Must have at least two testing staff meeting the following conditions:

- Having a professional qualification from a vocational high school or higher in one of the following fields: medicine, pharmacy, biology, chemistry;

- Holding a certificate of training in HIV testing issued by healthcare facilities designated by the Minister of Health or a certificate of training in HIV testing issued by an authorized foreign agency suitable for the testing technique they are assigned to perform.

b) Must have at least one counseling staff meeting the conditions stipulated in Clause 3, Article 26 of the Law on Prevention and Control of Viral Infections Causing Acquired Immunodeficiency Syndrome (HIV/AIDS) (hereinafter referred to as the HIV/AIDS Prevention and Control Law) in cases where blood is drawn and results are directly returned to the person undergoing HIV testing.

2. Infrastructure conditions:

In addition to meeting the infrastructure conditions prescribed in Clause 1, Article 5 of Decree No. 92/2010/ND-CP dated August 30, 2010 of the Government detailing certain provisions of the Law on Prevention and Control of Infectious Diseases concerning biosafety in laboratories (hereinafter referred to as Decree No. 92/2010/ND-CP), HIV testing laboratories using simple techniques must also meet the following additional conditions:

a) The area for conducting HIV tests:

- Must be separate from other areas for conducting tests within the laboratory;

- Must ensure good ventilation, cleanliness, dust-free, and moisture-proof;

- Must have adequate electricity and clean water supply.

b) The testing table must be placed in a well-lit location and away from air currents;

c) The walls of the testing area must be made of non-porous materials resistant to heat and corrosive chemicals, with a height of at least 50 cm from the tabletop;

d) There must be a hand washing sink located near the entrance of the laboratory;

đ) There must be a system for pre-treating waste before disposal into the general waste container.

3. Equipment conditions:

In addition to meeting the equipment conditions prescribed in Points b, c, and d of Clause 2, Article 5 of Decree No. 92/2010/ND-CP, HIV testing laboratories using simple techniques must also meet the following additional conditions:

a) Must have testing equipment appropriate for the testing technique currently being performed in the laboratory;

b) Must have separate storage equipment for reagents and specimens suitable for the testing capacity;

c) Must have pipettes suitable for the testing technique when pipettes are required;

d) Must have a timer.

4. Quality management conditions for testing:

a) Laboratory equipment must meet the following conditions:

- Must have equipment management records, including: equipment transfer records, machine history, usage logs, and user manuals in Vietnamese;

- Must have a summary of equipment usage instructions posted in a convenient location for reference during equipment use;

- Must be regularly maintained, serviced, and calibrated;

- Refrigerators for storing specimen and reagents must be monitored daily for temperature using a temperature log sheet or book and must have a backup power source.

b) Must fully implement control samples in the reagent kit according to the manufacturer's guidelines; it is encouraged to combine with internal control samples;

c) Must participate in external quality assessment programs for HIV testing;

d) HIV testing must meet the following conditions:

- Must follow the testing methods specified in Appendix 6 of Circular No. 09/2012/TT-BYT dated May 24, 2012 of the Minister of Health guiding epidemiological surveillance of HIV/AIDS and sexually transmitted infections (hereinafter referred to as Circular No. 09/2012/TT-BYT);

- Must follow the manufacturer's instructions for reagent use.

đ) Reagents used in HIV testing must have a valid registration number for circulation or be approved for use by the Ministry of Health and still be within their expiration date.

e) Test result records (written or printed or read) and test diagrams must be retained for five years from the date of testing for all HIV testing techniques.

Article 5. Conditions for HIV Testing Laboratories Using Immunoassay Techniques

1. Personnel Conditions:

In addition to meeting the conditions stipulated in Point b Clause 1 Article 4 of this Circular, HIV testing laboratories using immunoassay techniques must have at least two laboratory technicians who meet the following conditions:

a) Possessing a professional qualification from a vocational high school level or higher in one of the following fields: medicine, pharmacy, biology, chemistry, with the laboratory technician responsible for managing the laboratory having a bachelor's degree or higher;

b) Holding a certificate of training in HIV testing issued by healthcare facilities designated by the Minister of Health, or a certificate of training in HIV testing issued by competent authorities abroad that is appropriate to the testing technique they will perform.

2. Infrastructure conditions:

In addition to meeting the conditions stipulated in Clause 2 Article 4 of this Circular, HIV testing laboratories using immunoassay techniques must also meet the following additional conditions:

a) Having one deep sink for washing testing equipment made of non-porous material resistant to corrosive chemicals;

b) Having air conditioning or dehumidifying equipment.

3. Equipment conditions:

In addition to meeting the equipment conditions stipulated in Clause 3 Article 4 of this Circular, HIV testing laboratories using immunoassay techniques must also meet the following additional conditions:

a) Having at least one of the following three systems: ELISA machine system or chemiluminescence system or electrochemiluminescence system;

b) Having at least one centrifuge suitable for the testing technique;

c) Having at least one pipette set ensuring volume accuracy suitable for the testing technique being performed.

4. Quality Management of Testing: Meeting the conditions stipulated in Clause 4 Article 4 of this Circular.

Section 2. CONDITIONS FOR SEROLOGICAL TESTING LABORATORIES TO CONFIRM HIV

Article 6. Personnel Conditions

In addition to meeting the conditions stipulated in Clause 1 Article 5 of this Circular, serological testing laboratories to confirm HIV must also meet the following additional conditions:

1. Laboratory technicians directly performing tests in serological testing laboratories to confirm HIV must also meet the following additional conditions:

a) Having at least one year of experience in HIV testing;

b) Having basic knowledge about HIV and HIV testing techniques, as well as the ability to analyze and interpret test results;

c) Being familiar with relevant legal regulations related to HIV testing.

2. The person in charge and staff of serological testing laboratories to confirm HIV must meet the conditions stipulated in Clause 3 Article 5 Decree No. 92/2010/ND-CP.

Article 7. Conditions for Infrastructure

1. Meeting biosafety level I conditions as prescribed in Decree No. 92/2010/ND-CP and the conditions stipulated in Clause 2 Article 5 of this Circular. If the serological testing laboratory to confirm HIV conducts cell culture, isolation, or animal experiments, it must meet biosafety level III conditions as prescribed in Decree No. 92/2010/ND-CP.

2. Having backup power supply.

Article 8. Equipment Conditions

In addition to meeting the equipment conditions stipulated in Points b, c, and d Clause 2 Article 5 of Decree No. 92/2010/ND-CP, serological testing laboratories to confirm HIV must also meet the following additional conditions:

1. Having equipment suitable for the HIV testing techniques currently performed in the laboratory as specified in Section 1 Chapter II of this Circular.

2. Having a deep freezer with a temperature of at least -20^°C for storing positive or indeterminate specimen samples.

Article 9. Conditions for Quality Management

Meeting the quality management conditions stipulated in Clause 4, Article 4 of this Circular.

Article 10. Conditions for Conducting HIV Testing Capabilities

1. Experience Conditions for Conducting HIV Testing:

a) Having at least three months of experience conducting HIV testing according to Method III as prescribed in Appendix 6 issued together with Circular No. 09/2012/TT-BYT up until the date of submitting the application for recognition of the capability to confirm HIV positive cases.

b) During the period of conducting HIV testing as provided in Point a, Clause 1 of this Article, at least fifty suspected positive samples must be identified. In cases where testing is conducted using immunological assay techniques, there must be at least twenty instances of such technique being performed.

c) The verification results of each implementation of testing techniques must meet the requirements.

2. Full participation in external quality control programs for HIV testing, wherein the results of the two most recent external quality controls must meet the standards.

3. The storage of HIV-positive and suspected samples must be scientific, reasonable, and include all samples during the period of testing as specified in Point a, Clause 1 of this Article.

Section 3. CONDITIONS FOR THE NATIONAL REFERENCE LABORATORY FOR HIV SEROLOGICAL TESTING

Article 11. Personnel Conditions

In addition to meeting the conditions stipulated in Clause 3, Article 6 of Decree No. 92/2010/NĐ-CP and Clause 1, Article 6 of this Circular, the national reference laboratory for HIV serological testing must have at least eight staff members, including:

1. A responsible staff member with postgraduate qualifications in medicine or biology and at least five years of experience in conducting HIV serological testing.

2. Staff members assigned tasks related to quality management, standard sample set construction, and ensuring biosafety must have bachelor's degrees in medicine or biology and at least three years of experience in conducting HIV serological testing.

3. Other staff members must hold appropriate professional qualifications for their assigned tasks and must have at least one year of relevant work experience.

Article 12. Infrastructure Conditions

Meeting the conditions stipulated in Clause 1, Article 6 of Decree No. 92/2010/NĐ-CP.

Article 13. Equipment Conditions

In addition to meeting the equipment conditions stipulated in Clause 2, Article 6 of Decree No. 92/2010/NĐ-CP, the national reference laboratory for HIV serological testing must also meet the following additional conditions:

1. Basic testing equipment with a minimum quantity as follows:

a) Two ELISA systems, including one semi-automatic ELISA system and one fully automatic ELISA system;

- One three-dimensional shaker for performing Western Blot technique;

- One high-speed centrifuge (at least 15,000 rpm);

- Two magnetic stirrers;

- Two mixers;

- Two pipette sets suitable for the testing techniques currently employed by the laboratory;

- One deep freezer at -20°C for storing samples and chemicals used in the production of external and internal quality control samples;^°- One deep freezer at -70°C for storing samples for the establishment of an HIV sample bank;

- Three refrigerators with preservation temperatures ranging from 4-8°C, including one for storing biological products, one for storing samples, and one for producing external quality control samples;^°- One incubator at 37°C;

- One water bath;^°- One vacuum pump;

- One dedicated label printer for the laboratory.^°C;

b) Other equipment and consumables compatible with the testing techniques currently implemented in the laboratory.

- 01 vacuum pump;

- 01 dedicated label printer for the laboratory.

b) Other equipment and consumable materials suitable for the testing techniques currently being performed in the laboratory.

Article 14. Conditions for Quality Management and Capability to Conduct HIV Testing

1. Quality management conditions: Meeting the ISO 15189 standard or equivalent standards prescribed for laboratories. In cases where there is production and provision of external quality control and internal quality assurance samples, additional ISO 17043 standards must be met.

2. Conditions regarding capability to conduct HIV testing:

a) Possessing the ability to manage, coordinate, and provide external quality control and internal quality assurance programs for other HIV serology laboratories.

b) Possessing the ability to support the development of standardized procedures for HIV serological testing techniques to provide reference and implementation for other HIV serology laboratories.

c) Possessing the ability to develop serological testing methods for HIV and train on HIV serological testing techniques.

d) Having a sample bank to ensure the quality of HIV testing.

đ) Possessing the ability to collaborate or organize the implementation of scientific research related to HIV pathogenesis, immunology; evaluation of serological testing methods for HIV, the quality of reagents for serological testing for HIV in practice, and other relevant studies.

e) Being able to perform all serological testing methods for HIV simultaneously and having the ability to confirm HIV infection status from indeterminate reactions.

g) Participating annually in external quality control programs for HIV testing conducted by international agencies recognized by the Ministry of Health.

Chapter III

CONDITIONS FOR LABORATORIES CONDUCTING HIV TESTING USING BIOTECHNOLOGY TECHNIQUES

Article 15. Conditions for laboratories conducting HIV testing using molecular biology techniques

1. Personnel Conditions:

In addition to meeting the conditions stipulated in Clause 3, Article 6 of Decree No. 92/2010/ND-CP and Point b, Clause 1, Article 4 of this Circular, laboratories conducting HIV testing using molecular biology techniques must have at least two laboratory technicians who meet the following conditions:

a) Having a professional qualification of at least vocational high school level in one of the following fields: medicine, pharmacy, biology, chemistry, with the laboratory technician responsible for managing the laboratory having a postgraduate degree in medicine or biology.

b) Holding a certificate of training in HIV testing using molecular biology techniques issued by healthcare facilities designated by the Minister of Health, or a certificate of training in HIV testing issued by competent authorities abroad that is appropriate to the testing technique they will perform.

c) Having at least one year of experience in performing HIV testing using molecular biology techniques.

2. Infrastructure conditions:

In addition to meeting the conditions stipulated in Clause 1, Article 6 of Decree No. 92/2010/ND-CP, laboratories conducting HIV testing using molecular biology techniques must also meet the following conditions:

a) For laboratories using non-automatic and non-completely closed systems, there must be at least three separate units or areas designed according to the unidirectional principle in the following order:

- Chemical preparation room;

- Sample preparation room;

- Amplification room.

If the laboratory performs PCR testing techniques, in addition to the above rooms, there must be an additional room or area for analyzing PCR products.

b) For laboratories using fully automatic and completely closed systems: They must be designed to meet the requirements of the system.

3. Equipment conditions:

In addition to meeting the conditions stipulated in Clause 2, Article 6 of Decree No. 92/2010/ND-CP, laboratories conducting HIV testing using molecular biology techniques must also meet the following conditions:

a) Having testing equipment suitable for the testing techniques currently being performed at the facility and distributed in the following rooms:

- Chemical preparation room:

+ Refrigerator at 4°C and -20°C for storing chemicals and reagents;

+ Biological safety cabinet or PCR workbench with UV light and illumination lamps;

+ Centrifuge for 1.5-2 ml test tubes;

+ Shaker;

+ Pipette set for preparing reaction solutions.

- Sample preparation room (RNA/DNA extraction):

+ Class II biological safety cabinet;

+ Refrigerator at -80°C;

+ Refrigerator at 4°C;

+ Cold centrifuge for 2 ml and 5 ml test tubes;

+ Shaker;

+ Pipette set for extraction;

+ Timer;

+ Rotating shaker, thermal cycler (as required by the technique);

+ Sample preparation machine for processing and extracting (if available).

- Amplification room:

+ Thermal cycler for conventional molecular biology testing or Real Time PCR;

+ Centrifuge for 0.2-2 ml test tubes;

+ Pipette set suitable for each technique;

+ PCR workbench;

+ Refrigerator at 4°C for storing molecular biology products.

b) In cases where PCR testing techniques are used, the following equipment must be added in the PCR product analysis area:

- Electrophoresis apparatus, microwave, gel pouring equipment, gel reader and analyzer or ELISA machine for ELISA technique analysis;

- Separate pipette set;

- Refrigerator at 4°C.

c) Having consumables suitable for the molecular biology techniques currently being implemented.

4. Quality management conditions:

Meeting the quality management conditions stipulated in Points a, b, c, đ, and e, Clause 4, Article 4 of this Circular.

5. In cases where laboratories conduct HIV testing using molecular biology techniques for children under 18 months, they must also meet the following additional conditions:

a) Conditions regarding capability to conduct HIV testing:

- Having at least six months of experience in performing HIV testing using molecular biology techniques prior to the date of submission of the declaration application and detecting at least 20 suspected positive samples.

- The results of verification of each testing technique must meet the requirements.

b) Ensuring scientific, reasonable, and complete storage of HIV-positive and suspected samples during the testing period as stipulated in Point a, Clause 5.

Article 16. Conditions for the National Reference Laboratory for HIV Testing Using Molecular Biology Techniques

1. Personnel Conditions:

In addition to meeting the conditions stipulated in Clause 3, Article 6 of Decree No. 92/2010/NĐ-CP and Point b, Clause 1, Article 4 of this Circular, the laboratory must have at least five staff members, including:

a) A responsible staff member with a doctoral degree in medicine or biology and at least five years of experience conducting molecular HIV testing;

b) Staff members assigned tasks related to quality management, biosafety, and standard sample construction must hold a bachelor's degree in medicine or biology and have at least three years of experience conducting molecular HIV testing;

c) Other staff members must possess relevant professional qualifications and at least one year of experience in their assigned work.

2. Equipment and infrastructure conditions: Meeting the conditions stipulated in Clause 2, Article 15 of this Circular.

3. Equipment conditions: Meeting the conditions stipulated in Clause 3, Article 15 of this Circular.

4. Quality management conditions: Achieving ISO 15189 standards or equivalent standards for laboratories. In cases where there is production and provision of external and internal control samples, ISO 17043 standards must also be met.

5. Conditions for conducting HIV testing capabilities:

a) The ability to manage or provide external and internal quality control programs for molecular HIV testing laboratories;

b) The ability to develop standardized procedures for molecular testing techniques to be referenced and implemented by molecular HIV testing laboratories;

c) The ability to train molecular HIV testing techniques;

d) The ability to collaborate or organize the implementation of scientific research related to virology, molecular biology, and other relevant studies on HIV;

e) The ability to perform all HIV tests using molecular biology techniques;

f) Participation in annual external quality assurance programs conducted by reputable international organizations.

Chapter IV

PROCEEDINGS, PROCEDURES FOR AUTHORIZATION AND RECOGNITION OF HIV TESTING LABORATORIES

Section 1. PROCEDURES FOR ANNOUNCING HIV SCREENING TESTING LABORATORIES

Article 17. Documents for announcing an HIV screening testing laboratory that meets the conditions for conducting HIV screening tests

1. A notification document declaring the laboratory qualified to conduct HIV screening tests according to the model specified in Appendix 1 attached to this Circular.

2. A certified copy of the operating permit issued by the competent state authority for private healthcare facilities or a copy of the establishment decision issued by the competent state authority for public health facilities.

3. A list of laboratory personnel according to the model specified in Appendix 2 attached to this Circular. For laboratories within healthcare facilities, certified copies of the practicing certificates of laboratory personnel must also be submitted.

4. An inventory of infrastructure accompanied by a floor plan of the area where HIV testing technology is performed, stamped and signed by the head of the facility.

5. An inventory of medical equipment of the laboratory according to the model specified in Appendix 3 attached to this Circular.

Article 18. Procedures for Announcing a Laboratory Capable of Conducting HIV Screening Tests

1. Procedures for announcing a laboratory capable of conducting HIV tests for laboratories under medical examination and treatment facilities: The procedures for announcing a laboratory capable of conducting HIV tests are carried out simultaneously with the procedures for requesting issuance of a Business License for the facility.

2. Procedures for announcing a laboratory capable of conducting HIV tests for laboratories not under medical examination and treatment facilities:

a) Prior to 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 (hereinafter referred to as the provincial department).

b) Upon receiving the documents, the Provincial Department of Health sends the facility submitting the documents a receipt for submission of documents according to the model prescribed in Appendix 4 issued together with this Circular.

c) After fifteen working days from the date recorded on the receipt for submission of documents, if the Provincial Department of Health does not propose amendments or supplements, the facility is permitted to commence HIV testing activities.

d) In cases where the documents are not valid, within five working days from the date of receiving 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 and contents need to be supplemented or amended.

đ) Upon receiving the document requesting amendments and supplements, the facility announcing its capability to conduct HIV testing must carry out amendments and supplements according to the contents specified in the document and resubmit the amended and supplemented documents to the Provincial Department of Health.

e) After fifteen working days from the date recorded on the receipt for submission 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.

Section 2. DOCUMENTS AND PROCEDURES FOR ISSUING NEW AND REPLACEMENT CERTIFICATES FOR CONFIRMATORY HIV TESTING LABORATORIES

Article 19. Documents and Procedures for Issuing New Certificates for Confirmatory HIV Testing Laboratories

1. Documents for Requesting Issuance of New Certificates for Confirmatory HIV Testing Laboratories: To be implemented according to the provisions of Article 17 of this Circular.

2. Procedures for Receiving and Processing Requests for Issuance of New Certificates for Confirmatory HIV Testing Laboratories:

a) The facility requesting issuance of new certificates for confirmatory HIV testing laboratories (hereinafter referred to as the requesting facility) must submit one set of documents to the National Center for HIV/AIDS Prevention and Control - Ministry of Health. The date of receipt of the documents is calculated based on the stamp of receipt of the incoming document at the National Center for HIV/AIDS Prevention and Control - Ministry of Health.

b) Within five working days from the date of receiving the documents, if there is no request for amendment or supplementation of the documents, the National Center for HIV/AIDS Prevention and Control - Ministry of Health must issue a document designating the facility to assess the capacity to perform HIV testing (hereinafter referred to as the assessing facility) of the requesting facility.

c) In cases where the documents for requesting issuance of certificates for confirmatory HIV testing laboratories are not valid, within five working days from the date of receipt of the documents, the National Center for HIV/AIDS Prevention and Control - Ministry of Health must issue a document notifying the requesting facility to complete the documents. The notification document must specify the required additional documents and the necessary amendments.

d) Upon receiving the document requesting completion of the documents, the requesting facility must supplement and amend the documents according to the contents specified in the document and resubmit them to the National Center for HIV/AIDS Prevention and Control - Ministry of Health. The date of receipt of the supplementary and amended documents is calculated based on the stamp of receipt of the incoming document at the National Center for HIV/AIDS Prevention and Control - Ministry of Health. Within five working days from the date of receiving the supplementary documents, if the documents are valid, the National Center for HIV/AIDS Prevention and Control - Ministry of Health must proceed with the designation of the assessing facility.

đ) In cases where the requesting facility has supplemented and amended the documents but not in accordance with the requirements, the National Center for HIV/AIDS Prevention and Control - Ministry of Health will notify the facility to continue completing the documents according to the provisions of points c and d of this Clause.

3. Assessment of the Capacity to Perform HIV Testing of the Requesting Facility:

a) Within a maximum period of ten working days from the date of receiving the designation document from the National Center for HIV/AIDS Prevention and Control - Ministry of Health, the assessing facility must send the evaluation sample set for HIV testing capacity and the samples for reports serving the assessment of HIV testing capacity to the requesting facility.

b) Within a maximum period of twenty days from the date of receiving the designation document and the evaluation sample set for HIV testing capacity, the requesting facility must implement and submit a report on the assessment of HIV testing capacity to the assessing facility including:

- Test results and patient samples conducted by the requesting facility on thirty consecutive patient samples tested for HIV (including twenty positive reaction samples according to method III and ten negative reaction samples) for serological testing laboratories;

- Test results on the evaluation sample set for HIV testing capacity sent by the assessing facility.

c) Within ten working days from the date of receiving the report from the requesting facility, the assessing facility must conduct an assessment of the testing capacity on:

- Patient samples submitted by the requesting facility;

- Results of the evaluation sample set for HIV testing capacity sent by the assessing facility.

After completing the assessment, the assessing facility is responsible for sending the results to the National Center for HIV/AIDS Prevention and Control - Ministry of Health according to the model prescribed in Appendix 5 issued together with this Circular.

d) Within ten working days from the date of receiving the report from the assessing facility (the date of receipt of the report is calculated based on the stamp of receipt of the incoming document at the National Center for HIV/AIDS Prevention and Control - Ministry of Health), the National Center for HIV/AIDS Prevention and Control - Ministry of Health must proceed with the following procedures:

- In cases where the assessment results are satisfactory: Submit to the Minister of Health for consideration and decision to establish a verification team at the requesting facility.

- In cases where the assessment results are unsatisfactory: Issue a document notifying the requesting facility.

4. Organization of Verification to Issue New Certificates for Confirmatory HIV Testing Laboratories:

a) The Minister of Health establishes a verification team for the requesting facility consisting of the following components:

- A representative from the leadership of the National Center for HIV/AIDS Prevention and Control as the Team Leader;

- A representative from the Legal Affairs Department;

- A representative from the National Reference Laboratory for Serological HIV Testing;

- An independent expert in HIV testing;

- A staff member from the National Center for HIV/AIDS Prevention and Control as the Secretary.

b) Components collaborating during the verification process:

- A representative from one of the following institutes: the Central Institute for Hygiene and Epidemiology, the Ho Chi Minh City Pasteur Institute, the Nha Trang Pasteur Institute, or the Western Highlands Hygiene and Epidemiology Institute (hereinafter referred to as the Regional Institute), depending on the location where the facility requesting the HIV confirmatory laboratory certificate is situated;

- A representative from the Health Department of the province where the facility requesting the certificate is located;

c) The process for granting a new HIV confirmatory laboratory certificate:

- Reviewing legal documents; inspecting conditions regarding infrastructure, equipment, medical tools, and human resources organization of the requesting facility;

- Preparing the inspection record according to the model prescribed in Appendix 6 issued together with this Circular;

- The inspection record shall be made in five copies: one copy retained at the AIDS Prevention and Control Department - Ministry of Health, one copy retained at the Health Department of the province where the requesting facility is located, one copy retained at the National Reference Laboratory for Serological Testing of HIV, one copy retained at the Regional Institute, and one copy retained at the inspected facility;

- Within five working days from the date of completion of the inspection, the AIDS Prevention and Control Department must submit to the Ministry's leadership for consideration and decision on issuing the HIV Confirmatory Laboratory Certificate according to the model prescribed in Appendix 7 issued together with this Circular. In case of non-issuance, a written response stating the reasons must be provided;

5. Management of the HIV confirmatory laboratory certificate:

a) Each HIV confirmatory laboratory may only be granted one HIV confirmatory laboratory certificate valid for five years, starting from the issuance date;

b) Copies of the HIV confirmatory laboratory certificate and the application dossier for issuing a new or renewed certificate shall be kept at the authority issuing the HIV confirmatory laboratory certificate;

c) After issuing the HIV confirmatory laboratory certificate, the Ministry of Health shall send a notification letter to the People's Committee of the province and the Health Department of the province where the testing facility has been granted the HIV confirmatory laboratory certificate within thirty days from the issuance date;

Article 20. Dossier and procedures for reissuing the HIV confirmatory laboratory certificate

1. Reissuing the certificate applies in the following cases:

a) The certificate has expired;

b) The certificate is lost or damaged;

c) Change of person in charge or direct technical staff performing HIV testing;

d) Change in the location of the testing facility;

đ) Supplementing HIV testing techniques;

e) The certificate has been revoked;

2. Dossier and procedures for reissuing the HIV confirmatory laboratory certificate in case of loss or damage of the certificate:

a) The application dossier for reissuing the HIV confirmatory laboratory certificate includes:

- A request for reissuance from the facility with the HIV confirmatory laboratory according to the model prescribed in Appendix 8 issued together with this Circular;

- The previously issued HIV confirmatory laboratory certificate (if available);

b) The process for reissuing the HIV confirmatory laboratory certificate due to loss or damage of the certificate:

- Checking the stored inspection file at the Ministry of Health or the damaged HIV confirmatory laboratory certificate (if available);

- Within five working days from receiving the dossier, the AIDS Prevention and Control Department must submit to the Minister of Health for consideration and decision on reissuing the HIV confirmatory laboratory certificate;

3. Dossier and procedures for reissuing the HIV confirmatory laboratory certificate due to change of person in charge or direct technical staff performing HIV testing or change in the location of the testing facility:

a) The application dossier for reissuing the HIV confirmatory laboratory certificate: Follow the provisions set out in Point a Clause 2 of this Article;

b) The process for reissuing the HIV confirmatory laboratory certificate due to change of person in charge or direct technical staff performing HIV testing or change in the location of the testing facility:

- Within five working days from receiving the dossier, the AIDS Prevention and Control Department - Ministry of Health shall designate an inspection body to conduct an actual inspection at the requesting facility;

- Within fifteen working days, the inspection body must conduct an inspection of the conditions for performing technical testing at the requesting facility and report to the AIDS Prevention and Control Department along with the inspection record;

- Within a maximum of ten working days from receiving the inspection record from the inspection body, the AIDS Prevention and Control Department must submit to the Minister of Health for consideration and decision on reissuing the HIV confirmatory laboratory certificate according to the model prescribed in Appendix 7 issued together with this Circular;

4. For the cases stipulated in Points a, đ, and e Clause 1 of this Article, the procedures shall be implemented according to the provisions of Article 19 of this Circular.

Section 3. AUTHORITY, FILES, PROCEDURES FOR DESIGNATING NATIONAL REFERENCE LABORATORIES FOR HIV TESTING

Article 21. Authority to designate national reference laboratories for HIV testing

The Minister of Health shall designate an HIV testing laboratory under the state health system as the national reference laboratory for HIV testing.

Article 22. Procedures for Designating National Reference Laboratories for HIV Testing

1. The HIV/AIDS Prevention and Control Department shall send a document requesting the facility where the laboratory proposed to be designated as the national reference laboratory for HIV testing (hereinafter referred to as the proposed designated facility) to prepare a file including the documents specified in Clauses 2, 3, 4, and 5 of Article 17 of this Circular and submit it to the Ministry of Health.

2. Procedure for receiving and processing the file:

a) Within ten working days from the date of receipt of the file, if there is no request for supplementary information, the HIV/AIDS Prevention and Control Department of the Ministry of Health must issue a document to the Minister of Health for consideration and decision on the establishment of a verification team for the proposed designated facility;

b) In case the application file is not valid, within five working days from the date of receipt of the file, the HIV/AIDS Prevention and Control Department of the Ministry of Health must issue a notification to the proposed designated facility to complete the file. The notification must specify the required additional documents and the necessary amendments;

c) Within twenty days from the date of receipt of the request for completion of the file, the proposed designated facility must supplement and amend the file according to the contents recorded in the document and submit it to the HIV/AIDS Prevention and Control Department of the Ministry of Health. The date of receipt of the supplemented and amended file is calculated based on the stamp of receipt of the document at the HIV/AIDS Prevention and Control Department of the Ministry of Health;

Within five working days from the date of receipt of the supplemented file, if the file is valid, the HIV/AIDS Prevention and Control Department of the Ministry of Health must implement the proposal for the establishment of the verification team as stipulated in Point a of this Clause;

d) In case the proposed facility has supplemented and amended the file but does not meet the requirements, the HIV/AIDS Prevention and Control Department of the Ministry of Health will notify the facility to continue completing the file according to the provisions of Points b and c of this Clause.

3. Organization of Verification:

a) The Minister of Health establishes a verification team for the requesting facility consisting of the following components:

- A representative of the leadership of the HIV/AIDS Prevention and Control Department of the Ministry of Health serves as the Head of the Team;

- Independent experts in HIV testing; biosafety; quality management of HIV testing;

- A representative of the Legal Affairs Department of the Ministry of Health;

- A representative of the Medical Examination and Treatment Management Department of the Ministry of Health;

- A representative of the Preventive Medicine Department of the Ministry of Health;

- An officer of the HIV/AIDS Prevention and Control Department of the Ministry of Health serves as the Secretary of the Verification Team.

b) Verification Process: Implemented according to the provisions of Point c Clause 4 of Article 19 of this Circular.

Section 4. SUSPENSION OF HIV TESTING ACTIVITIES, REVOCATION OF CERTIFICATES FOR HIV CONFIRMATORY TESTING LABORATORIES

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. Lack of sufficient equipment for conducting tests or having testing equipment that is not operational or does not meet quality standards.

3. Not participating in external quality control programs.

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

5. Failure to conduct statistical reporting of HIV testing results.

Article 24. Authority to Suspend Activities

1. The Minister of Health decides on the suspension of activities of HIV confirmatory testing laboratories and national reference laboratories for HIV testing.

2. The Director of the Provincial Health Department decides on the suspension of activities of HIV screening testing laboratories.

Article 25. Procedures and time for suspending operations

1. During the process of inspecting and auditing the operation of HIV testing laboratories, if violations of any provisions set forth in Article 23 of this Circular are discovered, the inspection and audit unit must prepare a temporary suspension of operation record according to the model prescribed in Appendix 9 attached to this Circular and send it to the AIDS Prevention and Control Department under the Ministry of Health or the Medical Services Department under the Provincial Health Department.

2. Within five working days from the date of receipt of the temporary suspension of operation record specified in Clause 1 of this Article:

a) The AIDS Prevention and Control Department must submit to the Minister of Health for consideration and decision on suspending operations;

b) The Medical Services Department must submit to the Director of the Provincial Health Department for consideration and decision on suspending operations.

3. The decision to suspend operations has a term of six months from the date of signing and issuance and shall be sent as follows:

a) For confirmatory HIV testing laboratories and national reference laboratories for HIV testing: The entity where the suspended HIV testing laboratory is located and the units that participated in the certification of confirmatory HIV testing laboratories or the decision to designate national reference laboratories for HIV testing;

b) For screening HIV testing laboratories: The entity where the suspended HIV testing laboratory is located and the Provincial AIDS Prevention and Control Center.

4. In cases where the suspended HIV testing laboratory has taken corrective actions against violations, at least thirty days before the expiration date of the suspension decision, the entity where the suspended HIV testing laboratory is located must report on the corrective actions taken to:

a) The inspection entity specified in Point b Clause 2 Article 19 of this Circular for confirmatory HIV testing laboratories and national reference laboratories for HIV testing;

b) The Provincial AIDS Prevention and Control Center where the entity with the suspended HIV testing laboratory is located for screening HIV testing laboratories;

c) The receipt date of the violation correction report is calculated based on the receipt stamp of the incoming document of the entities specified in Points a and b of this Clause.

5. Within twenty working days from the date of receipt of the violation correction report from the suspended entity, the units specified in Points a and b Clause 3 of this Article must conduct inspections and report the inspection results to the AIDS Prevention and Control Department under the Ministry of Health or the Medical Services Department under the Provincial Health Department. The receipt date of the violation correction report is calculated based on the receipt stamp of the incoming document of the AIDS Prevention and Control Department under the Ministry of Health or the Provincial Health Department.

6. If the suspended entity has implemented corrective actions and met the requirements of this Circular, within five working days from the date of receipt of the reports from the units specified in Clause 3 of this Article:

a) The AIDS Prevention and Control Department under the Ministry of Health must submit to the Minister of Health for consideration and decision to terminate the suspension of operations. The decision to terminate the suspension of operations shall be sent to the entity where the suspended HIV testing laboratory is located and the units that participated in the certification of confirmatory HIV testing laboratories or the decision to designate national reference laboratories for HIV testing;

b) The Medical Services Department under the Provincial Health Department must submit to the Director of the Provincial Health Department for consideration and decision to terminate the suspension of operations. The decision to terminate the suspension of operations shall be sent to the entity where the suspended HIV testing laboratory is located and the Provincial AIDS Prevention and Control Center.

7. If, upon expiration of the suspension period for testing operations, the suspended entity has not taken corrective actions or has taken corrective actions but still does not meet the requirements of this Circular, within five working days from the expiration date of the suspension decision or from the date of receipt of the reports from the units specified in Clause 3 of this Article:

a) The AIDS Prevention and Control Department under the Ministry of Health must submit to the Minister of Health for consideration and decision to revoke the Certificate of Confirmatory HIV Testing Laboratory or the Decision to Designate National Reference Laboratory for HIV Testing of that entity;

b) The Medical Services Department under the Provincial Health Department must submit to the leadership of the Provincial Health Department for consideration and decision to terminate the screening HIV testing operations of that entity.

Article 26. Revocation of HIV Confirmatory Laboratory Certification and Decision on Designation of National Reference Laboratory for HIV Testing

Clause 1. The HIV confirmatory laboratory certification and decision on designation of national reference laboratory for HIV testing shall be revoked in the following cases:

a) As stipulated in Clause 7, Article 25 of this Circular;

b) The HIV confirmatory laboratory certification and decision on designation of national reference laboratory for HIV testing were issued beyond authority or contain contents contrary to the law;

c) The testing facility ceases operation, goes bankrupt, or is dissolved or merged;

d) The testing facility has its operating license revoked according to the regulations of the competent state management agency.

e) Using HIV testing reagents without a registration number for circulation or not approved by the Ministry of Health for use or have exceeded their expiration date.

Clause 2. The Minister of Health shall decide on the revocation of the HIV confirmatory laboratory certification and decision on designation of national reference laboratory for HIV testing.

Clause 3. Procedures for revoking the HIV confirmatory laboratory certification and decision on designation of national reference laboratory for HIV testing:

a) During the inspection or audit of the activities of an HIV testing laboratory that has been granted an HIV confirmatory laboratory certification or decision on designation of national reference laboratory for HIV testing, if violations of the provisions stipulated in Clause 1 of this Article are discovered, the inspecting or auditing unit must prepare a suspension activity record according to the model prescribed in Appendix 9 attached to this Circular and send it to the Department of HIV/AIDS Prevention and Control under the Ministry of Health;

b) Within five working days from the date of receipt of the suspension activity record as stipulated in Clause 1 of this Article, the Department of HIV/AIDS Prevention and Control under the Ministry of Health must submit to the Minister of Health for consideration and decision on the revocation of the HIV confirmatory laboratory certification or decision on designation of national reference laboratory for HIV testing;

c) The decision to revoke the HIV confirmatory laboratory certification and decision on designation of national reference laboratory for HIV testing shall be sent as follows:

- To the entity where the HIV testing laboratory whose HIV confirmatory laboratory certification or decision on designation of national reference laboratory for HIV testing was revoked is located;

- To the units that participated in the evaluation and issuance of the HIV confirmatory laboratory certification or decision on designation of national reference laboratory for HIV testing.

Chapter V

RESPONSIBILITIES FOR IMPLEMENTATION

Article 27. Responsibilities of HIV Testing Laboratories

Clause 1. Responsibilities of HIV Screening Testing Laboratories:

a) Conduct sample collection or reception for performing HIV detection techniques but shall not confirm positive HIV cases;

b) Participate in the external quality control program for HIV testing approved or designated by the Ministry of Health;

c) Organize HIV testing counseling, notify HIV test results in accordance with the provisions of the Law on HIV/AIDS Prevention and Control;

d) Implement statistical reporting of data as prescribed in Circular No. 09/2012/TT-BYT and keep complete records and store testing forms and books in accordance with the provisions of Decision No. 868/QD-BYT dated March 29, 2005 of the Minister of Health on issuing seven forms for HIV testing laboratories.

Clause 2. Responsibilities of HIV Confirmatory Testing Laboratories:

In addition to implementing the provisions stipulated in Clause 1 of this Article, HIV confirmatory testing laboratories must also perform the following responsibilities:

a) Receive samples suspected of being positive from HIV screening testing laboratories in the area or nearby regions to conduct HIV confirmation testing. Retain positive or suspected samples for two years from the date of confirmation testing at the laboratory;

b) Train, supervise technical support, and participate in annual inspections of HIV testing activities at screening testing facilities within their jurisdiction.

Article 28. Responsibilities of the National Reference Laboratory for HIV Testing

In addition to implementing the provisions stipulated in Clause 2, Article 27 of this Circular, the National Reference Laboratory for HIV Testing shall also undertake the following responsibilities:

1. Receiving samples suspected of being positive for HIV sent from HIV Confirmatory Laboratories.

2. Training, technical support, monitoring, and annual inspection of HIV Confirmatory Laboratories as assigned by the Ministry of Health.

3. Organizing the implementation and managing quality assurance for the HIV testing laboratory system.

Article 29. Responsibilities of the Department of HIV/AIDS Prevention and Control - Ministry of Health

1. Directing, inspecting, supervising, evaluating activities, and compiling activity data on HIV testing nationwide.

2. Directing facilities with National Reference Laboratories for HIV Testing to develop materials and organize training on HIV testing for units and localities.

3. Annually, organizing conferences to review and implement quality assurance work for HIV testing.

Article 30. Responsibilities of Provincial Health Departments

1. Directing and inspecting HIV testing activities within their province.

2. Proposing amendments and supplements to address shortcomings related to the implementation of quality assurance for HIV testing during the implementation of this Circular's regulations.

3. Cooperating with relevant departments to support and organize supervision over the implementation of HIV testing.

4. Annually reporting to the Ministry of Health a list of HIV Confirmatory Laboratories and HIV Screening Laboratories within their jurisdiction.

Chapter VI

IMPLEMENTING PROVISIONS

Article 31. Transitional Provisions

1. New or renovated HIV laboratories established after this Circular takes effect must comply with the conditions specified in this Circular.

2. Existing HIV laboratories operating before this Circular takes effect must have plans for renovation to meet all conditions specified in this Circular by December 31, 2014.

3. For HIV Screening Laboratories under healthcare facilities established before this Circular takes effect, they may continue operations but must complete procedures to declare compliance with HIV testing conditions as stipulated in Clause 2, Article 18 of this Circular by December 1, 2013.

4. HIV laboratories recognized by the Ministry of Health as meeting conditions for confirming positive HIV test results before this Circular takes effect may continue operations but must submit files as stipulated 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 August 30, 2014.

Where an 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 Ministry of Health leadership for consideration and decision on issuing a certificate for an HIV Confirmatory Laboratory.

Where an 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 Ministry of Health leadership for consideration and decision on revoking the recognition of the laboratory's qualification to confirm positive HIV cases that have been issued.

Article 32. Reference Provisions

In cases where the referenced documents in this document are replaced or amended, implementation shall be in accordance with the replacement or amended document.

Article 33. Effective Date

1. This Circular takes effect from July 1, 2013.

2. Decision No. 3052/2000/QĐ-BYT dated August 29, 2000 of the Minister of Health on issuing standards for laboratories authorized to confirm HIV positivity shall cease to be effective from the date this Circular takes effect.

Article 34. Responsibility for Implementation

The Director of the Ministry's Office, the Heads of the Department of HIV/AIDS Prevention and Control, the Departments, Bureaus, and General Bureaus under the Ministry of Health, the Heads of subordinate agencies and units of the Ministry, the Directors of Provincial Health Services under centrally governed cities and provinces, and the Heads of health agencies under other 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./.